99 results for Regulatory Director Jobs in Needham, MA, US

Responsible for leading CMC regulatory activities, generating high quality submissions for global investigational applications, collaborating with cross-functional teams, providing regulatory guidance, reviewing documentation, communicating with health authorities, and ensuring compliance with curre...

🚨Executive Director, Regulatory Affairs🚨Boston, MACompany Description:Clinical-stage biotech company, committed to developing antibody-based therapies for patients with complex diseases. Role Description:✅Early development of biologic programs✅Lead US and EU submissions✅Willing to work hands-on wh...

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells...

This position is a remote, within the United States.PURPOSE AND SCOPE:Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a critical role in influencing regulatory decisions, managing complex global submi...

Responsible for developing and implementing global/regional regulatory strategies for projects, leading the development of regulatory strategy, representing GRA on development teams, addressing complex regulatory issues, anticipating global regulatory changes, shaping regulatory submission documents...

Responsible for leading the strategic direction and execution of regulatory strategies for the global pharmaceutical portfolio, influencing regulatory decisions, managing complex global submissions, and ensuring successful product development and market access. Key responsibilities include overseein...

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also ...

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also ...

Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the team’s activities from IND-enabling studies and first-in-human (FIH) studies through clinical proof of concept (PoC) trials, and to facilitate post-PoC tr...

Associate Director/Director Regulatory AffairsWe are seeking an experienced Associate Director/Director of Regulatory Affairs to lead global regulatory submission activities across development programs. This strategic and hands-on role will be responsible for overseeing regulatory operations & s...