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 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 ...

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 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 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 ...

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 ...

About the Company · 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 t ...

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 ...

· 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 ...

· Company Description · Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on ...

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 ...

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 ...

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 ...

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

+ 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 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 ...

· Company Description · Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on ...

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. · The Sr. Director, Regulatory Affairs CMC will be responsible to ensure that Zenas is executing global regula ...

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, · a diverse pipeline of development programs across various diseases. · ...