NewDirector, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteBoston, MARemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
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.
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.
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.
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/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.
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.
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).
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, Business Process Office, Global Regulatory Affairs (GRA) TakedaSenior Manager, Business Process Office, Global Regulatory Affairs (GRA)MassachusettsRemoteThe 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. The Senior Manager, Global Regulatory Affairs (GRA) Business Process Office (BPO) is a key contributor who supports continuous improvement, process optimization, and operational excellence efforts across the GRA organization.
Manager, Regulatory Affairs Monte Rosa Therapeutics, IncManager, Regulatory AffairsBoston, Massachusettsp style="margin:0px">Researches 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.
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.
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.
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.
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.
Regulatory Affairs Manager II Post Market WerfenRegulatory Affairs Manager II Post MarketBedford, Massachusettsli>Lead 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.
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.
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.
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.
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.
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.
NewManager, Regulatory Affairs Advertising & Promotion (Work from Home) ParexelManager, Regulatory Affairs Advertising & Promotion (Work from Home)MassachusettsThis individual will act as a trusted advisor, collaborating across cross-functional teams within a large, dedicated client partnership—helping to influence regulatory strategy and deliver meaningful impact, all while working remotely. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk.
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.
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.
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.
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.
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.
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.
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.
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.
Sr. Manager, Technical Regulatory Compliance Johnson & JohnsonSr. Manager, Technical Regulatory ComplianceRaynham, MAThe position plays a critical role in managing compliance risk, supporting audit and inspection readiness, and enabling compliant execution of complex technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Senior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines CSL Behring LLCSenior Manager, Regional Regulatory Lead - North America, Seqirus VaccinesWaltham, MA$154,000–$182,000 / yearThe Senior Manager, Regional Regulatory Lead (RRL), North America Seqirus Vaccines in the Global Regulatory Strategy (GRS) team is a member of the GRA GRS Vaccines Therapeutic Area (TA) and contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
Regulatory Affairs Operations Manager Third Rock Ventures LLCRegulatory Affairs Operations ManagerCambridge, MAp>for more information visit urlhttps://recruiting.paylocity.com/Recruiting/Jobs/Details/4004149.
Senior Manager, Regulatory Affairs Hologic IncSenior Manager, Regulatory AffairsCambridge, MAp>Technical Documentation Specialist Role location: Cambridge, UK Discover a career with real meaning. Product DevelopmentEngineer Role location: Cambridge, UK Discover a career with real meaning.
Senior Manager, Regulatory Lead Takeda Pharmaceutical Co LtdSenior Manager, Regulatory LeadBoston, MA$137,000–$215,270 / yearAssists in the creation and submission of high quality, compliant regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines as per R&D and business objectives. 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.
Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu LtdDigital Assets Regulatory Management ManagerMA$144,600–$265,100 / yearp>Candidates joining our firm should possess an entrepreneurial drive, intellectual curiosity, creativity, and critical thinking in addition to the qualifications below: Strong oral and written communication skills, including the ability to support or lead business proposal development and sales presentations. Information for applicants with a need for accommodation: https://www2.deloitte.com/us/en/pages/careers/articles/join-deloitte-assistance-for-disabled-applicants.html.
Manager, Regulatory Policy and Stakeholder Engagement Eversource EnergyManager, Regulatory Policy and Stakeholder EngagementWestwood, MassachusettsRole and Scope of Position: Responsible for implementing strategic regulatory initiatives and developing and building key regulatory relationships that will enable the development of strong regulatory policy and drive regulatory successes. Current guidelines require employees to work at least three days in the office, including Tuesdays and Wednesdays, with the third day set by the employee and supervisor based on department needs.
Senior CMC Regulatory Strategy Manager GSK plcSenior CMC Regulatory Strategy ManagerWaltham, MA$144,375–$240,625 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company.
NewSenior Manager, CMC Global Regulatory Affairs Otsuka America PharmaceuticalSenior Manager, CMC Global Regulatory AffairsBoston, MAProvide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatoryrequirements and guidances. Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products.
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.
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.
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.
Manger, Transplant Quality & Regulatory Compliance Beth Israel Lahey HealthManger, Transplant Quality & Regulatory ComplianceBoston, Massachusetts120,000.00 USD - $150,000.00 USDThe pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law.
Manger, Transplant Quality & Regulatory Compliance Lahey Hospital and Medical CenterManger, Transplant Quality & Regulatory ComplianceBoston, MA$120,000–$150,000 / yearActual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. In this role, the Manager, Transplant QAPI & Regulatory Compliance provides leadership for transplant quality assessment, performance improvement, patient safety, and regulatory compliance across hospital solid organ transplant programs.
Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, IncDirector, Regulatory Affairs – Global Regulatory StrategyBoston, MassachusettsFull timeOverview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
Senior Regulatory Affairs Consultant - Regulatory Intelligence (Talent Pool) Parexel International CorpSenior Regulatory Affairs Consultant - Regulatory Intelligence (Talent Pool)MALead the client's internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities. In this consultative role, you will combine regulatory expertise, analytical rigor, and strong project leadership skills to navigate an evolving regulatory landscape while collaborating closely with clients, internal experts, and global teams.
Director, Regulatory Strategy – Global Regulatory Lead Beeline MedicinesDirector, Regulatory Strategy – Global Regulatory LeadBoston, MassachusettsDevelop and lead integrated global regulatory strategies for assigned pipeline programs in the I&I portfolio, encompassing pre-IND planning, IND/CTA submission strategy, Phase I/II/III development planning, and regulatory pathway optimization across major global jurisdictions including FDA, EMA, PMDA, and others. The Director, Regulatory Strategy – Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for the company's early-stage and pipeline programs in the immunology and inflammation (I&I) therapeutic area, with a particular focus on lupus and adjacent autoimmune indications.