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Keywords: Director, Regulatory Affairs Strategy, Location: Waltham, MA

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Director, Regulatory Affairs, Labeling

President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead... regulatory labeling or related strategy to successful conclusion for one or more products. Significant experience working...

Company: Alkermes
Location: Waltham, MA
Posted Date: 04 Sep 2025

Senior Manager/Associate Director, Regulatory Strategy

and diverse backgrounds are connected. The Sr. Manager/Associate Director, Regulatory Strategy, will be responsible for day... reports to the Senior Director, Regulatory Strategy and will be based in Watertown, MA, with the option of a hybrid work...

Posted Date: 09 Aug 2025
Salary: $142000 - 190000 per year

Vice President, Clinical and Medical Affairs

, Clinical and Medical Affairs, leading our clinical operations, evidence generation, and provider engagement and education... Leadership Team. The VP, Clinical and Medical Affairs will have primary responsibility for three strategic areas...

Company: Naveris
Location: Waltham, MA
Posted Date: 05 Oct 2025

Manager, Regional Regulatory Lead - US (Vaccines)

) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring... strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned product/s with a patient centric...

Company: CSL
Location: Waltham, MA
Posted Date: 21 Sep 2025

Senior Director, Market Development

with R&D, Medical Affairs, Market Access, and Regulatory teams to shape commercial strategies throughout the product... commercializes IBSRELA in Canada. Position Summary: Ardelyx is looking for a Senior Director, Market Development...

Company: Ardelyx
Location: Waltham, MA
Posted Date: 25 Oct 2025

Senior Director, Brand Lead, Nephrology

commercializes IBSRELA in Canada. The Senior Director, Brand Lead, Nephrology will be responsible for the overall brand strategy... and strategic focus, drive integrated marketing efforts, and oversee the thought leader engagement strategy, ensuring cohesive...

Company: Ardelyx
Location: Waltham, MA
Posted Date: 23 Oct 2025

Medical Director, Clinical Development

Job Description Role Summary We are seeking a driven and strategic Medical Director, Clinical Development to lead... to shape clinical strategy, serve as medical monitor, and collaborate cross-functionally to drive execution. Depending...

Company: Deciphera
Location: Waltham, MA
Posted Date: 23 Oct 2025

Senior Director, Pharmacovigilance Sciences Lead

teams such as Clinical Development, Regulatory Affairs, Quality, Medical Affairs and other relevant functions to maintain...Company Description Job Description Role Summary: The Senior Director, Pharmacovigilance Sciences Lead plays...

Company: Deciphera
Location: Waltham, MA
Posted Date: 11 Oct 2025

Senior Director, Pharmacovigilance Sciences Lead

teams such as Clinical Development, Regulatory Affairs, Quality, Medical Affairs and other relevant functions to maintain...Company Description Job Description Role Summary: The Senior Director, Pharmacovigilance Sciences Lead plays...

Company: Deciphera
Location: Waltham, MA
Posted Date: 10 Oct 2025

Director, Clinical Operations

teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership...The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical...

Company: Clinical Dynamix
Location: Watertown, MA
Posted Date: 08 Oct 2025

Medical Director, Pharmacovigilance

committee meeting to support key decision-making, drive conclusions and develop next steps Work closely with Regulatory Affairs...Job Description We are seeking a Medical Director. This position will report to the Senior Medical Director...

Company: Deciphera
Location: Waltham, MA
Posted Date: 02 Oct 2025

Medical Director, Oncology Clinical Development

development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability... of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology...

Company: GlaxoSmithKline
Location: Waltham, MA
Posted Date: 20 Sep 2025

Associate Director, Patient-Centered Outcomes Research (Oncology)

members from internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs... & Operations, Regulatory, Commercial). The Associate Director, Patient-Centered Outcomes Research, will support multiple programs...

Company: AbbVie
Location: Waltham, MA
Posted Date: 18 Sep 2025

Director, US HCP Immunology Marketing

HCPs to inform brand strategy and franchise planning Cross-Functional Leadership Partner closely with the Director...-rare disease patients who are in need of life saving treatments Job Description Sobi is seeking a Director, US HCP...

Company: Sobi
Location: Waltham, MA
Posted Date: 17 Sep 2025

Senior Director, Marketing – Alixorexton

Job Category: Commercial Degree Level: Bachelor's Degree Job Description: We are seeking a Senior Director... strategy and execution for a transformative, late-stage neuroscience asset during its most pivotal phase: the path to launch...

Company: Alkermes
Location: Waltham, MA
Posted Date: 07 Sep 2025

Medical Director, Clinical Development (Neurology)

and generation of clinical study reports. Additionally, the Medical Director will participate in internal strategy regarding future... therapeutic priorities and interact externally with key global regulatory authorities, industry and scientific organizations...

Company: Alkermes
Location: Waltham, MA
Posted Date: 29 Aug 2025

Associate Director, Scientific Communication

within Medical Affairs, the Associate Director, Scientific Communications will provide medical, scientific and technical expertise... to others external to Medical Affairs Partner with Medical Directors to develop and implement product specific strategy and alignment...

Company: Alkermes
Location: Waltham, MA
Posted Date: 13 Aug 2025

Senior Medical Director

, and a superior understanding of Medical Affairs and the compliant interplay with commercial brand teams, this role is Responsible... and will serve as the integrated medical affairs representative for cross-functional senior leadership teams including...

Company: Ardelyx
Location: Waltham, MA
Posted Date: 17 Oct 2025

Director, IT R&D Systems

all technology implementation, production support and maintenance activities for the Clinical, Regulatory and Medical Affairs... processes, procedures and content of managing IT delivery for Clinical, Regulatory, Medical Affairs, and Drug Safety...

Company: Alkermes
Location: Waltham, MA
Posted Date: 16 Oct 2025