Associate Director, Regulatory CMC - Cambridge, MA

Director, Regulatory Affairs - CMC (Individual Contributor) · Location: Flexible (U.S. based only, remote or hybrid options available) · Employment Type: Full-time · Summary: · A growing biopharmaceutical company is seeking a Director, Regulatory Affairs - CMC to lead global regu ...

SciPro partnered with a late-stage biotech seeking a Director, Regulatory CMC to join their team full-time. · This role leads global regulatory strategies and guides submissions ensuring compliance throughout product lifecycle. · ...

Director, Regulatory Affairs - CMC (Individual Contributor) · Location: Flexible (U.S. based only, remote or hybrid options available) · Employment Type: Full-time · Summary: · A growing biopharmaceutical company is seeking a Director, Regulatory Affairs - CMC to lead global regu ...

SciPro is partnered with an exciting late-stage biotech that is seeking a Director, Regulatory CMC to join their team full-time. · ...

We are seeking a Senior Director to lead our global Chemistry Manufacturing Controls regulatory strategy in Cambridge. This leader will be responsible for designing and executing global CMC regulatory strategies overseeing all CMC submissions and leading key health authority inte ...

+The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. · Lead site-specific post-approval change management activities... · ...

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 ...

· Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage co ...

We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. · The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level.This position leverages ...

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. · ...

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 computa ...

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 growing our Regulatory Affairs organization and are seeking a proactive and detail‑oriented professional to support global Regulatory CMC activities across our clinical programs.This is an exciting opportunity to contribute to high‑impact development efforts within a fast‑ ...

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 ...

The Executive Director will provide strategic leadership for global CMC regulatory activities across all stages of drug development and life cycle management. Reporting to the SVP Regulatory and Medical Writing this role serves as a liaison to health authorities driving regulator ...

· Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological ...

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. · We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and exce ...

+Takeda,+we+are+a+forward-looking,+world-class+R&D+organization+that+unlock+sustainability+,delivering transformative therapies to patients worldwide. · The Director Regulatory Site CMC ensures efficient management of regulatory change control activities at site level. · This pos ...