Senior Director of Regulatory Affairs

The Opportunity We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a...

About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMIs unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million...

Scismic is supporting the growth of a Boston-based biotechnology company that is discovering and developing novel medicines for cancer. We are seeking an Associate Director/Director of Regulatory Affairs to join the company. This candidate will be first in role and will report directly to the Head of Development Operations. This individual will provide...

Job#: 2025096 Job Description: Associate Director/Director, Regulatory Affairs 2025096 Location:  Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation,...

Scismic is supporting the growth of a Boston-based biotechnology company that is discovering and developing novel medicines for cancer. We are seeking an Associate Director/Director of Regulatory Affairs to join the company. This candidate will be first in role and will report directly to the Head of Development Operations. This individual will provide...

About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI’s unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy,...

Senior Manager/Associate Director, Regulatory StrategyCompany Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological...

Senior Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton.Position Overview: As the Senior Director of Regulatory Strategy, you...

Senior Manager/Associate Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the...

Senior Manager/Associate Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the...

Senior Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton.Position Overview: As the Senior Director of Regulatory Strategy, you...

Senior Manager/Associate Director, Regulatory StrategyCompany Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological...

Senior Manager/Associate Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the...

Senior Manager/Associate Director, Regulatory StrategyCompany Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological...

Our client is developing precision delivery platforms for the treatment of neurological and oncological disorders. They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Reporting into the Senior Director of Regulatory and Clinical Operations, you will be...

They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Reporting into the Senior Director Regulatory CMC, you will work closely with cross-functional teams, CMOs, and Health Authorities. This company...

Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ) Orchard Therapeutics Senior Director, Government Affairs in Boston , Massachusetts Location: Washington, DC or Boston, MA Reporting to: SVP, GM, North...

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...

Define and lead the execution of the global regulatory-CMC strategy from early- to late-phase development and NDA/MAA preparations. Provide strategic and operational support for small molecule pipeline. Represent regulatory-CMC on cross-functional project and technical teams. Develop regulatory-CMC strategies based on regulatory and technical experience,...