Director, Regulatory Affairs, CMC - Boston, 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 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 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 ...

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 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 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 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 ...

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 ...

+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. · +Define and lead the global CMC regulatory strategy across all ...

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. · ...

We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program. · This individual will be responsible for providing strategic regulatory direction and managing CMC related activities ...

We are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. · ...

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. · Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs) · Support regulatory agency interactions to ensure alignment on CMC strat ...

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. · ...

We are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-ch ...

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. · ...

Takeda is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. · ...

This is a job summary for the Senior Regulatory Affairs manager position. · ...

Author and compile CMC sections of regulatory applications Draft and maintain high-quality CMC regulatory documents Support regulatory interactions by preparing responses to CMC-related questions from FDA EMA PMDA and other global health authorities Execute CMC regulatory strateg ...

The Associate Director of Regulatory Affairs CMC will be responsible for developing global regulatory strategies to secure approval of manufacturing process under INDs/CTAs. · Developing innovative regulatory strategy for gene therapy products. · Designing effective global regula ...