Regulatory Affairs CMC - Westborough, MA

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, ...

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. · ...

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 ...

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. · ...

We are seeking an experienced Director Regulatory Affairs to lead global regulatory strategy and execution across both CMC · and clinical development programs. · This individual will serve as the strategic interface between Regulatory Affairs Technical Operations Quality Clinical ...

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 ...

Under the general direction of the CMC Regulatory Affairs team develop a Core Dossier for Module 2.3 and Module 3 CTD sections for a marketed product. · ...

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 ...

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 ...

Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery clinical development and commercialization of life-changing therapeutics for patients in need. They are seeking a Director Regulatory Affairs CMC to join their team. · ...

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 ...

We are seeking a Director, Regulatory , CMC to join our team. · This position reports to the Executive Director, Regulatory Affairs , CMC and will be based out of Boston . MA USA in our Needham office Hybrid positions require a minimum of two onsite days per week On-site position ...

This is a Director position for CMC Regulatory Affairs at GSK. · ...

This role will lead global Chemistry Manufacturing and Controls regulatory strategy for complex biological products · Lead CMC regulatory strategy for investigational and early commercial biological products across global teams. · Serve as a key strategic partner representing Glo ...

+ Lead Moderna's Regulatory CMC strategy for its oncology portfolio · + Manage a team of experts and steer regulatory submissions through all development stages · + Serve as senior voice in cross-functional governance structures · + Own regulatory interactions with global authori ...

This position is responsible for preparation of CMC submissions for Biologics 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. · We seek a recognized subject matter expert in Regulatory Affair ...

+ Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. The Sr. Director, Regulatory Affairs CMC will be responsible to ensure that Zena ...

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. · A BS, or advanced degree, preferably in chemistry or life/physical sciences · A minimum of 12 years regulato ...

We are seeking an experienced and strategic Senior Director, Regulatory Affairs – CMC to lead global CMC regulatory strategy across a diverse portfolio of small molecule and biologic development programs from early clinical development through commercialization. · This role is a ...