Director, Regulatory Affairs CMC - Somerville, MA

We are seeking an experienced and forward-thinking Director, Regulatory Affairs to lead global regulatory strategy and execution across both CMC and clinical development programs. · Provide strategic Regulatory CMC leadership across Generate's biologics portfolio, · Lead the plan ...

· About Generate:Biomedicines · Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology to create breakthrough medicines where novel therapeutics are comp ...

Antares Therapeutics is seeking an experienced Regulatory Affairs–CMC Strategist (Consultant) to provide senior strategic advisory leadership for global, phase-appropriate CMC regulatory strategies supporting early-stage small molecule product development. · Advanced degree (PhD, ...

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailer ...

We are seeking a Director, Regulatory Affairs to join our team. This position reports to the Executive Director and will be based out of Boston in our Needham office. Responsibilities include proposing and implementing global CMC regulatory strategies and providing guidance to cr ...

We are seeking a Director of Regulatory Affairs, CMC to support the development and execution of global regulatory strategies in the field of pharmaceuticals. The ideal candidate will have experience providing strategic regulatory guidance to drug development teams. · ...

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailer ...

The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under ...

Role Overview · We are seeking an experienced Associate Director, CMC Regulatory Affairs to lead and support global regulatory strategy for Chemistry, Manufacturing and Controls (CMC) across development programs. This role will provide strategic regulatory guidance for biologics ...

We are dedicated to developing better medicines for breast cancer and beyond. Our lead program is a complete estrogen receptor antagonist currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic b ...

We are seeking an experienced Director, Regulatory CMC to provide strategic and operational leadership for Chemistry, Manufacturing, and Controls regulatory activities across a growing portfolio of development and commercial products. · ...

+We are seeking a highly experienced Vice President, Regulatory Affairs, CMC to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. · +Define and lead the global CMC regulatory strategy across all ...

We are seeking a highly experienced Vice President, Regulatory Affairs, CMC to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. · We seek a recognized subject matter expert in Regulatory Affair ...

We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program. · This individual will be responsible for providing strategic regulatory direction and managing CMC related activities ...

About the Role · Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. · We are seeking a highly experienced Vice President, Regulatory Affairs, CMC to provide strategic and operational leadership for global ...

The Associate Director Regulatory Compliance will help develop and drive department-wide global regulatory compliance strategies ensuring Alnylam's program(s) meet global health authority requirements. · ...

+Job summary · The Associate Director Regulatory Compliance will help develop and drive department-wide global regulatory compliance strategies.These strategies will be designed to ensure Alnylam's program(s) meet global health authority requirements and remain compliant througho ...

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. · Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs) · Support regulatory agency interactions to ensure alignment on CMC strat ...

Takeda is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. · ...

At Viridian Therapeutics we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering we have created a robust pipeline of differentiated investigational therapeutic ...