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Regulatory Affairs Jobs in Waltham, MA

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Associate Director US Legal Affairs and Corporate Counsel Lundbeck

Boston, MA

Provide strategic counsel on FDA regulations, the False Claims Act, the Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, privacy and data security laws and regulations, and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales activities and compensation, pharmacovigilance, medical information, scientific exchange, and interactions with healthcare professionals. Serve as a strategic legal advisor to U.S. business functions, including Marketing, Medical Affairs, and Regulatory Affairs, providing legal counsel and guiding risk-based decision-making related to marketed pharmaceutical products, pipeline assets, and commercialization activities.

15 days ago

Medical Affairs Director - Movement Disorders Lundbeck

Boston, MA

This individual will partner closely with HEOR, Commercial, Customer Insights & Analytics, Patient Advocacy, Clinical Development, Compliance, Legal, Medical Affairs Operations, and Medical Affairs teams and external experts to ensure medical initiatives are scientifically rigorous, strategically aligned, compliant, and responsive to the evolving needs of the MSA community. The role will lead and contribute across medical strategy, launch readiness, evidence and data dissemination, external expert engagement, publication and congress planning, medical and digital content development, scientific platform development, promotional medical review, agency/vendor management, budget oversight, and compliance review.

1 day ago

Vice President, Franchise Clinical Lead, Oncology Takeda Pharmaceutical

Cambridge, MA

$321,000–$504,460 / year
Quick Apply

Consistent with the Takeda R&D Oncology Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regions. Part of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group: Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds.

1 day ago

SVP Quality Systems System One

Canton, MA

Quick Apply

Provide quality leadership from development through commercialization and lifecycle management, including design controls, technology transfer, validation, release, stability, post-market surveillance, complaints, field actions, and product changes. Partner with Operations, Manufacturing, Research & Development, Regulatory Affairs, Clinical, Medical Affairs, Supply Chain, Commercial, and other leaders to integrate quality into portfolio, capacity, supply, partnership, and operating decisions.

6 days ago

Deputy General Counsel Haffner's

Lawrence, MA

Quick Apply

Draft and negotiate purchase and sale agreements, leases, amendments, easements, and related transaction documents; coordinate legal due diligence, including title, survey, zoning, permitting, and environmental review; and support closings and post-closing obligations in collaboration with internal stakeholders, outside counsel, and consultants. Partner with business leaders, environmental, health and safety personnel, and the other Deputy General Counsel to identify regulatory obligations, develop and maintain policies and procedures, and address compliance risks, including those related to environmental protection, fuel storage and handling, and property acquisition, development, and use.

Today

Senior Regulatory Affairs Specialist Boston Scientific

Marlborough, MA

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed.

25 days ago

Director, Regulatory Affairs Massachusetts League of Community Health Centers

Boston, MA

Full time
Quick Apply

Support the development of an array of training and technical assistance vehicles for various levels of health center stakeholders including written materials, webinars, and standing committees/meetings (including CFO Peer to Peer, CFO Forum, Governmental Affairs Committee) to provide timely information and support regarding health center regulatory policy changes. Established under the same federal authorizing legislation as the health center program (Section 330 of the Public Health Service Act), PCAs are organized around a set of core functions and competencies that provide a framework for support and assistance to health centers and the communities they serve.

30+ days ago

Associate Director, Regulatory Affairs Third Rock Ventures LLC

Boston, MA

Support Phase II PoC & Phase III Readiness; Develop Phase II protocols with Go/No-Go criteria and strategies to de-risk psychiatry/neurology programs; Prepare Phase III regulatory groundwork, including End-of-Phase II (EOP2) meeting packages, safety database planning, and alignment with ICH guidelines for multi-regional trials. Design integrated early development strategic plans that bridge preclinical data (toxicology, pharmacology, CMC) with Phase I/II clinical objectives, addressing unique psychiatry/neurology challenges (e.g., blood-brain barrier delivery, placebo response mitigation).

28 days ago

Principal Regulatory Affairs Specialist Meridian Bioscience Inc

North Billerica, MA

$145,000–$185,000 / year

The Principal Regulatory Affairs Specialist collaborates with cross-functional stakeholders to ensure products remain compliant with applicable regulatory requirements and supports organizational objectives related to product lifecycle management, market expansion, risk management, and regulatory excellence. The Principal Regulatory Affairs Specialist serves as a senior technical leader and regulatory subject matter expert responsible for developing and executing global regulatory strategies throughout the product lifecycle.

8 days ago

Associate Director, Regulatory Affairs Seaport Therapeutics

Boston, Massachusetts

27 days ago

Principal Regulatory Affairs Specialist Boston Scientific

Marlborough, MA

Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.

30+ days ago

Senior Director, Regulatory Affairs Repertoire Immune Medicines

Watertown, MA

Full time

Reporting to the Chief Medical Officer, the Senior Director will own and be accountable for global regulatory strategy and execution from Phase 1/2 development through registrational planning in the U.S., EU, UK, and support activities in Asia-Pacific, partnering closely with Clinical Development, Clinical Operations, CMC, Quality, and external regulatory partners. Provide strategic regulatory guidance on early clinical development, including positioning Phase 1 programs for successful Phase 2 development and expedited programs, designations, and approval pathways (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, PRIME, Accelerated Approval).

12 days ago

Manager, Regulatory Affairs, CMC Stoke Therapeutics Inc

Bedford, MA

$145,000–$160,000 / year

Position Purpose: The Regulatory CMC Manager is responsible for contributing to the development of Stoke's products by supporting global CMC regulatory strategies, leading lifecycle management initiatives, and providing regulatory guidance to cross-functional teams for multiple programs. Key Responsibilities: Prepares and executes global regulatory CMC strategy for development programs and future commercial programs, including new applications, information amendments, annual reports, supplements/ variations, and responses to health authority questions.

21 days ago

Associate Director, Regulatory Affairs Alnylam Pharmaceuticals Inc

Cambridge, MA

$170,900–$231,300 / year

The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data packages to the US FDA and other international health agencies (HA). Additional responsibilities include involvement in thewriting and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on regulatory requirements worldwide, and interpreting regulatory intelligence for the internal teams.

30+ days ago

Associate Director, Global Regulatory Affairs ImCheck Therapeutics SAS

Cambridge, MA

Building Relationships with Regulators: Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Communication: Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.).

26 days ago

Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

Bedford, MA

$145,000–$160,000 / year

21 days ago

Associate Director, Global Regulatory Affairs - Ad / Promo BioNTech SE

Cambridge, MA

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. You'll lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), ensuring alignment with regulatory requirements while supporting our commercial success.

12 days ago

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

South Boston, MA

$165,000–$180,000 / year

The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.

30+ days ago

Associate Director, CMC Regulatory Affairs Vertex Pharmaceuticals

Boston, Massachusetts

$166,400–$249,600 / year

We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products.

17 days ago

Associate Director, Global Regulatory Affairs Ipsen SA

Cambridge, MA

26 days ago

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Regulatory Affairs Jobs in Waltham, MA

Associate Director US Legal Affairs and Corporate Counsel Lundbeck

Medical Affairs Director - Movement Disorders Lundbeck

Vice President, Franchise Clinical Lead, Oncology Takeda Pharmaceutical

SVP Quality Systems System One

Deputy General Counsel Haffner's

Senior Regulatory Affairs Specialist Boston Scientific

Director, Regulatory Affairs Massachusetts League of Community Health Centers

Associate Director, Regulatory Affairs Third Rock Ventures LLC

Principal Regulatory Affairs Specialist Meridian Bioscience Inc

Associate Director, Regulatory Affairs Seaport Therapeutics

Principal Regulatory Affairs Specialist Boston Scientific

Senior Director, Regulatory Affairs Repertoire Immune Medicines

Manager, Regulatory Affairs, CMC Stoke Therapeutics Inc

Associate Director, Regulatory Affairs Alnylam Pharmaceuticals Inc

Associate Director, Global Regulatory Affairs ImCheck Therapeutics SAS

Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

Associate Director, Global Regulatory Affairs - Ad / Promo BioNTech SE

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

Associate Director, CMC Regulatory Affairs Vertex Pharmaceuticals

Associate Director, Global Regulatory Affairs Ipsen SA

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