Associate Director, Regulatory CMC - Cambridge, MA

We are seeking an experienced CMC Regulatory Lead to provide strategic and operational leadership for all Chemistry, Manufacturing, and Controls (CMC) regulatory activities. · Develop and execute global CMC regulatory strategies to support IND, CTA, NDA/BLA, and lifecycle submiss ...

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.This role will serve as the CMC regulatory ...

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 ...

+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 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 ...

We are seeking a Senior Director, Regulatory CMC to lead global Chemistry, Manufacturing & Controls (CMC) regulatory strategy across a dynamic development and commercial portfolio. · Develop and own the global CMC regulatory strategy for assigned programs from early development t ...

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. · We pursue this audacious vision because we believe in the unique and revolutionary power of genera ...

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 ...

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, ...

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 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 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. · ...

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 val ...

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 ...

The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. This includes leading site-specific post-approval change management activities, applying science- and risk-based approaches to ...

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 ...

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases. · ...

+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 ...

+Job summary · PepGen is at an exciting time in our development. · This role is for a motivated and team-orientated individual who flourishes in an environment where they can help lead and shape our future. · +Able to command the attention and lead higher level managers and senio ...