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Regulatory Affairs Manager Jobs in Boston, MA

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New!

Boston, MA5 days ago

li>Strong hands-on knowledge of LAN/WAN protocols and technologies including Carrier Ethernet, T1, DS3, optical, DWDM, NTP, Spanning Tree, VLAN's, 802.1q, VFR, LFA, SMTP, SNMP v1-v3, OSPF, BGP, MPLS, VPLS, Ethernet, TCP/IP, SSL, SSH, SIP, H.323, QoS, Multicast, Anycast, 802.1x, Radius, NAC, DHCP, DNS, F5 Wide-IP, VRRP, HSRP, GLBP, PBR, VPC, LACP, SGT, SGACL, SXP, VxLAN, OTP, LISP, SPAN, WCCP, PfR, IPSLA, iWAN, VPN, IPSec, Wi-Fi 6, 6E, 7.

Proven experience and success with planning, installing and managing networks including LAN, MAN, WAN, Optical Networking, DWDM, Wi-Fi, Silverpeak SDWAN or Riverbed WAN Optimizers, F5 Load Balancers, F5 GTM Global Traffic Manager, Cisco Catalyst Center, and security (firewalls, VPN, DMZ, IDS/IPS, WebProxy, content filter, FireEye, NAC and Cisco TrustSec) infrastructure.

Lowell, Massachusetts18 days ago

$105,000–$125,000 Per Year

p style="margin:0px">The 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. Position Overview:

PGI .

Bedford, Massachusetts30+ days ago

li>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.

Waltham, MA30+ days ago

Dentsply 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.

New!

Burlington, Massachusetts6 days ago

$110,000–$150,000 Per Year

li style="margin:0in 1in 0in 0.5in">Provide 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.

New!

Burlington, MA5 days ago

$110,000–$150,000 Per Year

li>Provide 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.

Cambridge, MA30+ days ago

$160,000–$185,000 Per Year

Responsibilities: 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.

Boston, Massachusetts30+ days ago

p 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.

Cambridge, MA30+ days ago

$144,400–$195,400 Per Year

em> 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.

Nashua, NH11 days ago

Remote

p>The 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.

Boston, MA30+ days ago

$102,330–$125,070 Per Year

An 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.

Massachusetts19 days ago

Remote

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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. 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.

Cambridge, MA30+ days ago

$139,672–$188,968

li class="MsoNormal" style="color:#444444;background:white;vertical-align:baseline">Manage timelines and coordinate inputs across Technical Operations, Analytical, and Quality teams to ensure clear, consistent, and high-quality submissions using Regulatory eCTD templates. As 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.

MA30+ days ago

This 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.

Needham, Massachusetts30+ days ago

Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. style="min-height:1.5em">Bachelor’s degree in a scientific discipline with 8+ years of regulatory documentation and operations experience in a pharmaceutical, biotechnology or contract research organization (CRO), including experience in project coordination and document management systems and processes.

Boston, MA28 days ago

This 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.

Boston, MA30+ days ago

p>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.

Waltham, MA30+ days ago

$116,000–$160,000 Per Year

The 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).

Cambridge, MA30+ days ago

$139,672–$172,536 Per Year

As 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.

Boston, MA30+ days ago

$137,000–$215,270 Per Year

p>This 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.

Westford, MA30+ days ago

$99,300–$198,700 Per Year

Certification 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.

New!

Watertown, MA4 days ago

$145,000–$215,000 Per Year

Having 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.

Cambridge, MA30+ days ago

Responsibilities: • 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.

Waltham, California18 days ago

Oruka’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.

Waltham, MA22 days ago

$161,000–$187,000 Per Year

Oruka'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.

Waltham, MA30+ days ago

$100–$126 Per Hour

In 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.

Cambridge, MA30+ days ago

for more information visit urlhttps://recruiting.paylocity.com/Recruiting/Jobs/Details/4004149.

Cambridge, MA30+ days ago

p>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.

Ayer, Massachusetts13 days ago

The 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.

Joining ACI means becoming part of a diverse team of talented people who want to build their careers while contributing back to society in a positive way.

Ayer, Massachusetts13 days ago
The 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.
Joining ACI means becoming part of a diverse team of talented people who want to build their careers while contributing back to society in a positive way.

New!
Ayer, MA3 days ago
Ability 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.

Boston, MA20 days ago
$260,000–$360,000 Per Year
p>This 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.

Boston, MA19 days ago
Full-time
li class="TableParagraph" style="margin-left:8px">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. This 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.

New!
Cambridge, MA5 days ago
$170,900–$231,300 Per Year
Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on US regulatory requirements, and interpreting regulatory intelligence for the internal teams.
Serve as member of/or lead the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.

Waltham, MA30+ days ago
p>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.

Waltham, MA30+ days ago
$210,000–$270,000 Per Year
p>The Director of Regulatory & Clinical Affairs will oversee and lead the Regulatory Affairs Department to ensure global regulatory requirements are met for Nova products, including compliance with US FDA CFR Title 21 Part 820 (Quality System Regulation), ISO 13485:2016, Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch. This role serves as Deputy Person Responsible for Regulatory Compliance (PRRC) and is responsible for the leadership, development, and management of an effective and compliant Regulatory Affairs team, working closely with cross-functional partners to ensure processes meet regulatory expectations and support operational excellence.

Boston, MA30+ days ago
This 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).

Boston, Massachusetts30+ days ago
FICERA 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.
Develop and execute integrated global regulatory strategies to advance investigational oncology assets from early development through approval and lifecycle management, partnering closely with the VP, Regulatory Affairs.

Billerica, MA18 days ago
$182,100–$273,100 Per Year
Your Role: The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. About SpringWorks Therapeutics: SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors.

Waltham, MA30+ days ago
$210,000–$270,000 Per Year
ul>
Oversees and leads the Regulatory Affairs function to ensure global regulatory requirements are met for Nova products including but not limited to: U.S. FDA 21 CFR Part 820 (Quality Management System Regulation (QMSR), ISO 13485:2016,; EU Regulation (EU) 2017/746 (IVDR); UK Medical Devices Regulations 2002 (UK MDR 2002); Australian Therapeutic Goods (Medical Devices) Regulations 2002 (incl. Reggiannini%40aicompanies.com%7Cf6fba6f305dd4f5db48208dd4cfb41b1%7Cef83c7bf14e34752af743ef60a50e893%7C0%7C0%7C638751364205790035%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=EsnZO9uH6fllGdFfgcxIXEsPp3qEXFI%2FT5rnvjqL6MU%3D&reserved=0" rel="nofollow noopener noreferrer" target="_blank">https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW.

Boston, Massachusetts18 days ago
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At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Woburn, MA30+ days ago
Brief 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.

Woburn, MA21 days ago
ul>
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.

Boston, MA30+ days ago
This 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.

Waltham, Massachusetts28 days ago
p>Your 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.â¯ .

New!
MA5 days ago
Pulpdent 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.

Cambridge, MA30+ days ago
By harnessing AIs powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drugs will perform and develop innovative medicines to treat and cure some of the worlds most devastating diseases.
Knowledge Base: Profound knowledge of global registration processes, ICH guidelines, and direct experience serving as the primary liaison to global health authorities.

MA30+ days ago
$255,800–$402,700 Per Year
em> 10% Travel Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.

Waltham, MA30+ days ago
$250,000–$310,000 Per Year
p>Role Summary:
The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne''s regulatory operations. This position requires a leader who contributes to department-wide strategy, develops corporate policies and processes that influence the organization''s direction, and ensures alignment with the mission of delivering meaningful outcomes for patients.

Waltham, MA27 days ago
$295,600–$347,764 Per Year
p>Your Role:
The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts.?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.?Manage and develop staff, if required, including staff professional development and project oversight accountability.?.

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Regulatory Affairs Manager Jobs in Boston, MA

Sr. Network Architect ECLARO

Regulatory Affairs Manager PGI Foods

Regulatory Affairs Manager II Post Market Werfen

Regulatory Affairs Manager Dentsply Sirona Inc

Manager, Regulatory Affairs LeMaitre

Manager, Regulatory Affairs LeMaitre Vascular Inc

Senior Manager, Regulatory Affairs Nuvalent Inc

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

Senior Manager, Regulatory Affairs Getinge AB

Policy Manager, Government and Regulatory Affairs Blue Cross and Blue Shield of Massachusetts Inc

Senior Manager, Business Process Office, Global Regulatory Affairs (GRA) Takeda

Manager Regulatory Affairs, CMC Akebia Therapeutics

Senior Manager, Regulatory Affairs NAM Straumann Holding AG

Senior Manager, Regulatory Affairs, Operations Xenon Pharmaceuticals

Senior manager global regulatory affairs Katalyst Healthcares & Life Sciences

Manager, Regulatory Affairs Monte Rosa Therapeutics Inc

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Manager Regulatory Affairs CMC Akebia Therapeutics Inc

Senior Manager, Global Regulatory Affairs CMC Takeda Pharmaceutical Co Ltd

Regulatory Affairs Project Manager - Vascular (on-site) Abbott Laboratories

Senior Manager, Regulatory Affairs Kymera Therapeutics Inc

Manager/Senior Manager Regulatory Affairs - Advertising, Labeling, and Promotion Beam Therapeutics Inc

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics Inc

Contractor, Sr. Manager/AD, Regulatory Affairs StratAcuity Staffing Partners Inc

Regulatory Affairs Operations Manager Third Rock Ventures LLC

Senior Manager, Regulatory Affairs Hologic Inc

Regulatory Affairs Associate Ajinomoto Cambrooke, Inc.

Regulatory Affairs Associate Ajinomoto Health & Nutrition North America, Inc.

Regulatory Affairs Associate:$71,449+ YR Ajinomoto Cambrooke, Inc.

Vice President, Regulatory Affairs Rhythm Pharmaceuticals Inc

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Director, Regulatory & Clinical Affairs Nova Biomedical Corp

Sr Regulatory Affairs Spec Medtronic Plc

Senior Director, Regulatory Affairs Bicara Therapeutics

Director, Global Labeling - Regulatory Affairs SpringWorks Therapeutics Inc

Director, Regulatory Affairs Nova Biomedical

Director, Global Regulatory Affairs Process Excellence and Transformation Vertex Pharmaceuticals

Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals Inc

Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - US

Principal Regulatory Affairs Specialist Medtronic Plc

Vice President, Regulatory Affairs *PC 884 Miltenyi Biotec

Head of Regulatory Affairs Pulpdent Corp

Head of Global Regulatory Affairs and Strategy Isomorphic Labs Limited

Executive Director, Regulatory Affairs Merck & Co Inc

Executive Director, Regulatory Affairs Dyne Therapeutics Inc

Vice President, Regulatory Affairs *PC 884 Miltenyi Biotec GmbH

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