Senior Director, Global Regulatory Strategy, Therapeutic Area Lead

Job Description The Director, Global Regulatory Lead, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.   Leads the Global Regulatory Product Team (GRPT).  Continually expands TA knowledge, and ensures strategic messaging and content of global...

The Role: Moderna is seeking a Senior Director, Clinical Operations to manage therapeutics programs across the Therapeutics portfolio with a focus on Rare Diseases. The Senior Director, Clinical Operations, Therapeutics will function as a portfolio lead with oversight of programs and the clinical operations team(s) on those programs. This position will work...

Associate Director, Regulatory Strategy Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with...

Job Description Manager, Global Regulatory Affairs About This Role The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products. You are a member of the Regulatory Project Team for assigned programs and work with direction from...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

Description We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States . Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach using scientific rationale and in alignment with...

Company Address: 399 Binney Street, 2nd Floor, Cambridge, MA , 02142About Relay Therapeutics Relay Therapeutics is committed to creating medicines that will have a transformative impact on patients by building a unique discovery platform centered on understanding how the conformation of proteins relate to function. About Relay Therapeutics Relay Therapeutics...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

Job Description About This Role The Senior Manager, Scientific Communications is a member of the Global Scientific Capabilities department within Medical Affairs and is responsible for the strategic planning and execution of high-quality scientific communications deliverables. This person will report to the Director, Scientific Communications for Rare...

Associate Director/Director, Global Safety Lead Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

The Opportunity: We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to help define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the regulatory representative on relevant project teams and...

What this position is all about: We are looking for a strategic and results-driven Head of Regulatory Affairs (level commensurate with experience) to lead our regulatory efforts and activities for the advancement of our assets through early clinical development. This individual will play a pivotal role in shaping the regulatory strategy, ensuring compliance,...

Job Description About This Role As the Associate Director of Insights & Analytics (I&A) Strategy and Communication, you will play a key role in translating data into insights and communicating them across teams. You will work closely with the I&A teams across all therapeutic areas to deliver high-quality and impactful deliverables, such as CEO, Board & LT...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

Job Description About This Role  Biogen’s BNA Marketing Operations team consists of dedicated Pod teams for each therapeutic area, along with pipeline therapies and above brand digital technology and innovation initiatives. Each Pod team within Marketing Operations will have a dedicated team that includes a senior lead from Marketing, Regulatory, Legal...

Job DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

Job DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....