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Director, Global Regulatory Affairs, Neuroscience Takeda

Boston, Massachusetts

$177,000–$278,080 / year

Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.

3 days ago

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Waltham, MA

$116,000–$160,000 / year

ROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera's platform in clinical studies, QINLOCK (ripretinib) is Deciphera's switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

30+ days ago

Manager, Regulatory Affairs Deciphera

Waltham, MA

$116,000–$160,000 / year

30+ days ago

Consultant II, Regulatory Affairs Advertising and Promotion Syner-G

Boston, MA

Remote

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. The Consultant II serves as a key regulatory partner to Commercial, Medical, Legal, and Global Regulatory teams, enabling timely and compliant execution of brand strategy across product launch and lifecycle activities.

30+ days ago

AstraZeneca -CVRM Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Boston, MA

$60,315–$85,192.50 / year

The CVRM Regulatory Affairs Fellow is not only a learning and development opportunity to understand the drug development process and the Regulatory Affairs role - this role provides strategic and operational regulatory support to the development, commercialization and life cycle management of assigned products. As experience increases, the Fellow will have increasing responsibility and may serve as the regional regulatory lead for assigned programs, contributing to crafting and implementing the clinical strategy and influencing stakeholders to improve outcomes.

21 days ago

Senior Regulatory Affairs Specialist Hologic Inc

Cambridge, MA

$40,000–$50,000 / year

To deliver on that purpose, we need strong regulatory expertise that helps bring new products to market, keeps mature products compliant, and ensures our submissions, labeling, technical files, and product documentation meet global regulatory expectations. This role is ideal for a regulatory professional with strong knowledge of US, EU, and Canadian requirements who enjoys working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and international regulatory teams.

30+ days ago

Manager, Regulatory Affairs Deciphera Pharmaceuticals

Waltham, Massachusetts

$116,000–$160,000 / year
Full time

ROMVIMZA® (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

1 day ago

Global Regulatory Affairs Manager, Oncology GSK plc

Waltham, MA

$138,750–$231,250 / year

GSK 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. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head and collaborate with cross-functional teams to shape development plans and regulatory interactions across multiple regions.

8 days ago

Senior Manager, Regulatory Affairs US Lead AstraZeneca Plc

Boston, MA

$135,624.80–$203,437.20 / year

At Alexion (AstraZeneca's Rare Disease unit), work centres on people living with rare conditions whose journeys demand new thinking every day; this means operating at the edge of science while staying grounded in real patient stories, collaborating across subject areas to turn complex biology into transformative medicines, learning fast in an entrepreneurial environment with the backing of a global biopharma, and growing through tailored development that deepens both leadership capability and compassion for patients and communities we serve. Role Overview: The Senior Manager, Regulatory Affairs US lead will be responsible for leading, planning, preparing and delivering regulatory strategies and activities for assigned product(s)/project(s) across the assigned jurisdiction supporting global regulatory strategies, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

22 days ago

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Full time

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.

30+ days ago

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Westford, Massachusetts

$129,300–$258,700 / year

Lead regulatory strategy for on-market and sustaining activities, including product changes, regulatory impact assessments, maintenance of existing registrations/approvals, and other post-market regulatory activities throughout the product lifecycle. Maintain expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicate such knowledge to all internal stakeholders.

5 days ago

Associate Director, Global Regulatory Affairs CMC Takeda

Boston, Massachusetts

Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. 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: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.

30+ days ago

VP, Regulatory Affairs Prime Medicine Inc

Cambridge, MA

$313,000–$348,000 / year

Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies.

19 days ago

Director, Regulatory Affairs Advertising and Promotions Definium Therapeutics Inc

Cambridge, MA

$215,000–$255,000 / year

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. This position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, and Legal functions for the purpose of providing regulatory advice and guidance during promotional plan development from concept to field implementation, assuring conformity with FDA requirements, PhRMA DTC Guidelines, and Definium policies.

21 days ago

Director, Regulatory Affairs, Global Labeling Strategy US Alnylam Pharmaceuticals Inc

The Director of Global Labeling (GL) US will play a lead role in building and refining Alnylam's global labeling strategy processes and capabilities; supervise junior labeling strategists and provide strategic guidance in the development and maintenance of Company Core Data Sheets (CCDS), country product information (CPI) for Alnylam's products, and development of Target Label Profiles (TLP) for investigational therapies or uses. Ensure the implementation of differentiated global labeling strategies and Target Label Profiles that articulate the intended product value, priority claims, evidence requirements, risks, and negotiation pathways.

21 days ago

Spring 2027 Co-Op, Global Regulatory Affairs - Strategy And Operations Vertex Pharmaceuticals, Inc

Boston, MA

$30–$55 / hour

For the reports and activities that occur on a set cadence - quarterly off-site meetings, goals progress, organizational changes and new starters/leavers (announcements, org charts), hiring updates, organizational health - automate updates, including mechanisms for collecting or implementing inputs with scheduled, tracked workflows that can be adjusted in real time. Transition Support: Work in close collaboration with Chief of Staff to support an active key transition project within GRA, through involvement in developing work products/plans, tracking key milestones, and building content to support integration activities, as needed.

16 days ago

Spring 2027 Co-op, Global Regulatory Affairs - Strategy and Operations Vertex Pharmaceuticals Inc

Boston, MA

$30–$55 / hour

15 days ago

Spring 2027 Co-op, Global Regulatory Affairs – Strategy and Operations Vertex Pharmaceuticals

Boston, Massachusetts

$30–$55 / hour

For the reports and activities that occur on a set cadence – quarterly off-site meetings, goals progress, organizational changes and new starters/leavers (announcements, org charts), hiring updates, organizational health - automate updates, including mechanisms for collecting or implementing inputs with scheduled, tracked workflows that can be adjusted in real time. Transition Support: Work in close collaboration with Chief of Staff to support an active key transition project within GRA, through involvement in developing work products/plans, tracking key milestones, and building content to support integration activities, as needed.

14 days ago

Intellia Therapeutics - Global Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Boston, MA

$60,315–$85,192.50 / year

Intellia Regulatory Affairs Fellowship Program Overview: Northeastern University Pharmaceutical Industry Fellowships Program is a 2-year experiential program designed to advance lifelong learning and the education and training of PharmD graduates. In the second year, the Fellow will have the opportunity to select between the two disciplines, honing skills they developed during the first year and taking a deeper dive into specialized regulatory activities to provide the Fellow with a strong understanding of the drug development and approval landscape, and global regulatory frameworks.

21 days ago

Dompe- Global Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Boston, MA

$60,315–$85,192.50 / year

Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm. With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role.

21 days ago

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Production Jobs in Enumclaw, WA

Director, Global Regulatory Affairs, Neuroscience Takeda

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Manager, Regulatory Affairs Deciphera

Consultant II, Regulatory Affairs Advertising and Promotion Syner-G

AstraZeneca -CVRM Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Senior Regulatory Affairs Specialist Hologic Inc

Manager, Regulatory Affairs Deciphera Pharmaceuticals

Global Regulatory Affairs Manager, Oncology GSK plc

Senior Manager, Regulatory Affairs US Lead AstraZeneca Plc

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Associate Director, Global Regulatory Affairs CMC Takeda

VP, Regulatory Affairs Prime Medicine Inc

Director, Regulatory Affairs Advertising and Promotions Definium Therapeutics Inc

Director, Regulatory Affairs, Global Labeling Strategy US Alnylam Pharmaceuticals Inc

Spring 2027 Co-Op, Global Regulatory Affairs - Strategy And Operations Vertex Pharmaceuticals, Inc

Spring 2027 Co-op, Global Regulatory Affairs - Strategy and Operations Vertex Pharmaceuticals Inc

Spring 2027 Co-op, Global Regulatory Affairs – Strategy and Operations Vertex Pharmaceuticals

Intellia Therapeutics - Global Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Dompe- Global Regulatory Affairs Postdoctoral Research Fellow Northeastern University

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