Director, Regulatory Affairs CMC - Somerville

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 ...

· Role: Regulatory Affairs-CMC Strategist (Small Molecules) · Location: Boston, MA or Remote (East Coast hours preferred) · Type: Fractional/Part-time/Consultant · Commitment:  ~5–10 hours/week; increased support during key submissions · Compensation:  $300-$350/hr · Job Summary ...

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 ...

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 ...

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. · ...

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 Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under ...

We are dedicated to developing better medicines for breast cancer and beyond. Our lead program is a complete estrogen receptor antagonist currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic b ...

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. · ...

The Associate Director Regulatory Compliance will help develop and drive department-wide global regulatory compliance strategies ensuring Alnylam's program(s) meet global health authority requirements. · ...

+Job summary · The Associate Director Regulatory Compliance will help develop and drive department-wide global regulatory compliance strategies.These strategies will be designed to ensure Alnylam's program(s) meet global health authority requirements and remain compliant througho ...

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 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 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 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 Associate Director, Regulatory Affairs CMC to join our team at Olema Oncology. As a key member of our regulatory affairs group, you will be responsible for developing and executing CMC regulatory strategies for our product(s) in development and post-approval. · ...

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. · ...

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 ...