Senior Manager, Regulatory Affairs Nuvalent IncSenior Manager, Regulatory AffairsCambridge, MA$160,000–$185,000 / yearResponsibilities: Participates as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy; work closely with regulatory operations and program management to track timelines and ensure deliverables are achieved. Manage regulatory submission processes, develop and maintain regulatory tracking tools and infrastructure, as assigned Conduct regulatory intelligence and competitive intelligence and summarize key impacts to global strategy development teams, as appropriate.
NewSenior Manager, Regulatory Affairs NAM Straumann GroupSenior Manager, Regulatory Affairs NAMAndover, MAThis role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.
Senior Manager, Regulatory Affairs NAM Straumann Holding AGSenior Manager, Regulatory Affairs NAMMAThis role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.
Manager, Regulatory Affairs LeMaitreManager, Regulatory AffairsBurlington, Massachusetts$110,000–$150,000 / yearFull timeProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.
Manager Regulatory Affairs CMC Akebia Therapeutics IncManager Regulatory Affairs CMCCambridge, MA$139,672–$172,536 / yearAs we expand our portfolio across early and late-stage programs, we are looking for a Manager, Regulatory Affairs CMC who will thrive in a team-oriented, solutions-focused environment and is looking to play a visible, hands-on role in shaping regulatory strategy and execution. Manage timelines and coordinate inputs across Technical Operations, Analytical, and Quality teams to ensure clear, consistent, and high-quality submissions using Regulatory eCTD templates.
Policy Manager, Government and Regulatory Affairs Blue Cross and Blue Shield of Massachusetts IncPolicy Manager, Government and Regulatory AffairsBoston, MA$102,330–$125,070 / yearAn employee's pay position within the salary range will be based on several factors including, but limited to, relevant education, qualifications, certifications, experience, skills, performance, shift, travel requirements, sales or revenue-based metrics, and business or organizational needs and affordability. Learn how we are dedicated to creating an inclusive and rewarding workplace that promotes excellence and provides opportunities for employees to forge their unique career path by visiting our Company Culture page.
Manager, Regulatory Affairs Deciphera Pharmaceuticals IncManager, Regulatory AffairsWaltham, MA$116,000–$160,000 / yearThe Manager, Regulatory Affairs will partner cross-functionally to support high-quality regulatory submissions and help drive successful interactions with global health authorities. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).
Manager, Regulatory Affairs LeMaitre Vascular IncManager, Regulatory AffairsBurlington, MA$110,000–$150,000 / yearProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals IncSr. Manager Regulatory Affairs CMCCambridge, MA$144,400–$195,400 / yearem> Helps to lead the interpretation of regulatory expectations for emerging modalities, including: siRNA and oligonucleotide therapeutics Conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities) Complex drug substance and drug product configurations Helps to assess CMC implications of new technologies and modalities, including: Impact on product characterization, control strategies, and specifications Regulatory classification considerations (e.g., small-molecule vs biologic paradigms) Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. Broad understanding of: Drug substance and drug product development Analytical characterization and control strategies Regulatory framework across major regions (e.g., US, EU, Japan, China) Strong ability to integrate scientific, technical, and regulatory considerations into clear strategies #LI-KB1 #LI-Hybrid U.S. Pay Range $144,400.00 - $195,400.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting.
Senior Manager, Regulatory Affairs Getinge ABSenior Manager, Regulatory AffairsNashua, NHRemoteThe Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.
Manager, Regulatory Affairs Monte Rosa Therapeutics, IncManager, Regulatory AffairsBoston, MassachusettsFull timeResearches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.
Senior Manager, Regulatory Affairs Kymera Therapeutics IncSenior Manager, Regulatory AffairsWatertown, MA$145,000–$215,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Reporting to the Director of Regulatory Affairs, the Senior Manager will independently lead regulatory activities at the study level, acting as the regulatory representative on cross-functional teams while driving execution of program regulatory strategies.
NewSr. Manager, Regulatory Affairs, CMC AlnylamSr. Manager, Regulatory Affairs, CMCCambridge, MA$144,400–$195,400 / yearThis role will play a critical part in shaping regulatory strategies for emerging and complex modalities, withan emphasis on oligonucleotide-based therapeutics, including siRNA and novel conjugate delivery systems. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people.
Regulatory Affairs Manager Dentsply Sirona IncRegulatory Affairs ManagerWaltham, MADentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Regulatory Affairs Project Manager - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Project Manager - Vascular (on-site)Westford, MA$99,300–$198,700 / yearCertification is a plus (such as RAC from the Regulatory Affairs Professionals Society).Previous experience with 510k / PMA submissions Experience working with hardware/ software devicesFamiliarity with Predetermined Change Control Plans (PCCPs)Experience with Medical DevicesMust be able to juggle multiple and competing prioritiesExercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutionsHas a sound knowledge of a variety of alternatives and their impact on the businessApply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. WHAT YOU'LL DO Provide regulatory input to product lifecycle planningMonitor regulatory outcomes of initial product concepts and provide input to senior regulatory managementAssist in the development of multi-country regulatory strategy and update strategy based upon regulatory changesAssist in regulatory due diligence for potential and new acquisitionsUtilize technical regulatory skills to propose strategies on complex issuesMonitor trade association positions for impact on company productsAnticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Manager, Regulatory Affairs Monte Rosa Therapeutics IncManager, Regulatory AffairsBoston, MAResearches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.
Senior Manager, Regulatory Affairs, Operations Xenon PharmaceuticalsSenior Manager, Regulatory Affairs, OperationsNeedham, MassachusettsOur Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Regulatory Affairs Manager PGI FoodsRegulatory Affairs ManagerLowell, Massachusetts$105,000–$125,000 / yearFull timeThe Regulatory Affairs Manager serves as the company's regulatory expert and trusted business partner, ensuring that products, ingredients, packaging, and labeling comply with all applicable regulatory requirements while supporting the successful launch of new products. If you're a strategic regulatory professional who enjoys partnering across departments, navigating complex food regulations, and driving continuous improvement, this is an opportunity to make a significant impact while advancing your career with a growing company.
Regulatory Affairs Manager II Post Market WerfenRegulatory Affairs Manager II Post MarketBedford, MassachusettsFull timeLead field corrections and removal for on-market products, determining classification and regulatory agency reportability based on assessed risk, preparing comprehensive regulatory strategy, authoring field communication, leading cross-functional team to ensure timely customer notification, reporting and interfacing with regulatory agencies (as required), and supervising the regulatory team that assembles and maintains the necessary support records. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program.
NewSenior Manager, Global Regulatory Affairs CMC EMD GroupSenior Manager, Global Regulatory Affairs CMCNorth Billerica, MA$134,200–$202,200 / yearYour Role: The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document as well as all CMC Dossier types, their content and decision making on content, for assigned submissions worldwide, and serves as the Regulatory Affairs CMC contact point and acts as the liaison with the GHO and R&D functions, being the contact person for all Regulatory CMC topics. Develops, authors and owns the CMC dossier Strategy Document as well as all CMC Dossier types; being accountable for CMC Dossier content and content decision of all CMC Dossier types such as IMPD/IND, BB (incl.
Manager Regulatory Affairs-Chemistry Manufacturing & Controls CMC AbbVie IncManager Regulatory Affairs-Chemistry Manufacturing & Controls CMCWaltham, MARepresents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position.
Sr. Manager/Associate Director, Regulatory Affairs Oruka TherapeuticsSr. Manager/Associate Director, Regulatory AffairsWaltham, CaliforniaOruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.
NewDirector, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesBoston, MA$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
NewSenior Regulatory Affairs Manager Katalyst Healthcares & Life SciencesSenior Regulatory Affairs ManagerBoston, MADevelop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities. This includes formulating the global Nonclinical / Clinical strategy for the Global Regulatory Plan, acting as the key liaison with Health Authorities and leading the preparation of Nonclinical / Clinical documentation to support global regulatory filings, including post-approval activities and life-cycle expansion opportunities.
NewSenior Regulatory Affairs Manager Katalyst Healthcares and Life SciencesSenior Regulatory Affairs ManagerBoston, MADevelop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities. This includes formulating the global Nonclinical / Clinical strategy for the Global Regulatory Plan, acting as the key liaison with Health Authorities and leading the preparation of Nonclinical / Clinical documentation to support global regulatory filings, including post-approval activities and life-cycle expansion opportunities.
Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics IncSr. Manager/Associate Director, Regulatory AffairsWaltham, MA$161,000–$187,000 / yearOruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.
Manager - North American Solution Consulting - Regulatory Veeva Systems IncManager - North American Solution Consulting - RegulatoryBoston, MA$110,000–$175,000 / yearNice to Have Previous work at a technology vendor in the Pharma, Biotech, or MedTech space Previous experience working in the life sciences industry at a sponsor or CRO Knowledge of the end-to-end Regulatory process and concepts End-user and/or Administrator experience with Veeva products (Vault RIM) or other Regulatory Operations software Experience with Artificial Intelligence (AI) or other advanced technical tools and concepts Perks & Benefits Medical, dental, vision, and basic life insurance Flexible PTO and company paid holidays Retirement programs * 1 charitable giving program Compensation Base pay: $110,000 - $175,000 The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Requirements Bachelors degree in a related field 3 years of management experience 5 years of pre-sales Solution Consulting experience Demonstrated success in selling SaaS/cloud enterprise solutions Experience with managing recruiting and hiring pre-sales consultants Excellent communication and organization skills Energetic self-starter thrives in fast-paced dynamic environments Proactive solutions-oriented problem solver who follows through and drives outcomes Ability to travel ~20% for internal & customer meetings, industry conferences, etc.
Senior Manager, Global Regulatory Affairs CMC Takeda Pharmaceutical Co LtdSenior Manager, Global Regulatory Affairs CMCBoston, MA$137,000–$215,270 / yearThis role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the teams delivery of critical functions as follows: With some supervision, leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Senior manager global regulatory affairs Katalyst Healthcares & Life SciencesSenior manager global regulatory affairsBoston, MAThis role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows. RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
Principal Regulatory Affairs Specialist Medtronic PlcPrincipal Regulatory Affairs SpecialistBoston, MAThis role is responsible for shaping and executing global regulatory strategies, with a strong focus on pre-market submissions and early engagement with the global regulatory partners and/or regulatory authorities, as appropriate, across the United States, European Union, China, Japan, and Australia. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, China PTR submissions, and EU MDR Technical Documentation.
NewSenior manager global regulatory affairs Katalyst Healthcares and Life SciencesSenior manager global regulatory affairsBoston, MAThis role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: This role is within in the GRA Chemistry Manufacturing &Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows. RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical StrategyWoburn, MAul>Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.
Vice President, Head of Regulatory Affairs Zevra TherapeuticsVice President, Head of Regulatory AffairsBoston, MassachusettsThis leader owns the global regulatory strategy and execution across the portfolio consisting of commercial products and development assets. The VP of RA demonstrates exceptional leadership skills and a passion for fostering professional growth within their team as well as improving the internal processes in the department.
Manager/Senior Manager Regulatory Affairs - Advertising, Labeling, and Promotion Beam Therapeutics IncManager/Senior Manager Regulatory Affairs - Advertising, Labeling, and PromotionCambridge, MAResponsibilities: • Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling. Position Overview: The Manager/Senior Manager, Regulatory - Advertising, Labeling, and Promotion (ALP) is responsible for leading U.S. promotional regulatory strategy and supporting ex-U.S.
Contractor, Sr. Manager/AD, Regulatory Affairs StratAcuity Staffing Partners IncContractor, Sr. Manager/AD, Regulatory AffairsWaltham, MA$100–$126 / hourIn terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
Regulatory Affairs Associate Ajinomoto Cambrooke, Inc.Regulatory Affairs AssociateAyer, MassachusettsFull timeThe employee will on occasion be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety shoes, safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines. • Assist with RAM with investigating and resolving discrepancies related to packaging, labeling or documentation, and collaborating with internal teams to implement rapid, compliant solutions.
NewRegulatory Affairs Associate:$71,449+ YR Ajinomoto Cambrooke, Inc.Regulatory Affairs Associate:$71,449+ YRAyer, MAAbility to sit for extended periods, perform visual inspections of labels/documents, occasional lifting up to 25 lbs., standing/walking/bending as needed. Perform regulatory research, document reviews, label proofreading, version control, and cross-functional coordination to enable compliant product release.
Regulatory Affairs Associate Ajinomoto Health & Nutrition North America, Inc.Regulatory Affairs AssociateAyer, MassachusettsFull timeThe employee will on occasion be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety shoes, safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines. • Assist with RAM with investigating and resolving discrepancies related to packaging, labeling or documentation, and collaborating with internal teams to implement rapid, compliant solutions.
Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals IncDirector, Regulatory Affairs - Clinical StrategyWoburn, MABrief Team/Department Description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical Strategy will conduct in-depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. Principle Responsibilities: • Development and implementation of clinical regulatory strategies and tactics, including but not limited to, Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets, while considering FDA and other health authority clinical and regulatory requirements.
Clinical & Regulatory Manager - Dialysis Operations (RN) - Northeast Region (CT/MA/NY/RI) American Renal Associates Holdings IncClinical & Regulatory Manager - Dialysis Operations (RN) - Northeast Region (CT/MA/NY/RI)Boston, MARemoteThis data-driven role serves as the regional clinical subject matter expert by proactively identifying gaps in clinical practice and opportunities to improve patient outcomes, and escalating findings to appropriate corporate clinical and operational leaders to drive aligned, actionable improvements. Summary: The Clinical & Regulatory Manager (CRM) is an RN with dialysis expertise who leads clinical quality, regulatory compliance, and outcome improvement across clinics in Massachusetts, Rhode Island, Connecticut, New York.
Vice President, Regulatory Affairs Rhythm Pharmaceuticals IncVice President, Regulatory AffairsBoston, MA$260,000–$360,000 / yearThis leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.
Sr Regulatory Affairs Spec Medtronic PlcSr Regulatory Affairs SpecBoston, MAThis role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Associate Director Regulatory Affairs Viridian Therapeutics IncAssociate Director Regulatory AffairsWaltham, MAp>Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian's Thyroid Eye Disease (TED) and TSHR portfolio. Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions.
Manager of Regulatory Compliance Signature HealthcareManager of Regulatory ComplianceBrockton, MAConducting detailed data analysis to identify trends, risks, and areas for improvement in regulatory compliance and patient safety, the Manager utilizes data to inform decision-making and develop actionable insights related to accreditation and payor contracts. We believe our distinctive Signature Healthcare team approach is the way healthcare should be: medical professionals across many locations communicating and collaborating, taking advantage of technologies and resources to make a difference in the lives and health of our patients.
Senior Director, Regulatory Affairs Bicara TherapeuticsSenior Director, Regulatory AffairsBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
NewExecutive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical Co LtdExecutive Director, Global Regulatory Affairs CMC Early DevelopmentBoston, MA$238,000–$374,000 / yearAccountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator's brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).
Head of Global Regulatory Affairs, Oncology TakedaHead of Global Regulatory Affairs, OncologyBoston, Massachusettsdiv>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. Minimum BS degree; advanced degree (MS, MBA, PhD or MD) preferred with 15+ years of industry experience in Regulatory Affairs development with responsibilities for major aspects of strategic planning, implementation and delivery of clinical programs, ideally withing Oncology.Vice President, Regulatory Affairs *PC 884 Miltenyi BiotecVice President, Regulatory Affairs *PC 884Waltham, MassachusettsYour Role: The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts.â¯The role will oversee industry-specific practices, ensure all government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets all set requirements and guidance’s. Lead team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement.â¯Manage and develop staff, if required, including staff professional development and project oversight accountability.⯠.Head of Regulatory Affairs Pulpdent CorpHead of Regulatory AffairsMAPulpdent is third-generation family-owned business that is widely respected for its innovative products and authentic company culture, which promotes work-life balance, employee retention, and product excellence. The Head of Regulatory Affairs will lead and evolve Pulpdent's global regulatory strategy across the full product lifecycle-from R&D and commercialization to quality assurance and post-market surveillance.Regulatory Affairs Operations Manager Third Rock Ventures LLCRegulatory Affairs Operations ManagerCambridge, MAp>for more information visit urlhttps://recruiting.paylocity.com/Recruiting/Jobs/Details/4004149.12345678Similar Job SearchesLaw Assistant Jobs in Burlington, MARegulatory Manager Jobs in Waltham, MARegulatory Manager Jobs in Marlborough, MARegulatory Manager Jobs in Cambridge, MARegulatory Manager Jobs in Newton, MA
Vice President, Regulatory Affairs *PC 884 Miltenyi BiotecVice President, Regulatory Affairs *PC 884Waltham, MassachusettsYour Role: The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts.â¯The role will oversee industry-specific practices, ensure all government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets all set requirements and guidance’s. Lead team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement.â¯Manage and develop staff, if required, including staff professional development and project oversight accountability.⯠.
Head of Regulatory Affairs Pulpdent CorpHead of Regulatory AffairsMAPulpdent is third-generation family-owned business that is widely respected for its innovative products and authentic company culture, which promotes work-life balance, employee retention, and product excellence. The Head of Regulatory Affairs will lead and evolve Pulpdent's global regulatory strategy across the full product lifecycle-from R&D and commercialization to quality assurance and post-market surveillance.
Regulatory Affairs Operations Manager Third Rock Ventures LLCRegulatory Affairs Operations ManagerCambridge, MAp>for more information visit urlhttps://recruiting.paylocity.com/Recruiting/Jobs/Details/4004149.