Manager, Global Regulatory Affairs

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...

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...

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....

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...

The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows: Job Description: Pay: 75.00-86.54/hr on W2. 6-month assignment to start with potential for extension or conversion. Qualifying candidates...

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...

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,...

Responsibilities: However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements, and may support business development activities. Recognize, exemplify, and adhere...

Job Description The Head of Global Medical Affairs will provide strategic leadership to develop an integrated medical affairs strategy with a significant impact on Bicycle’s current and emerging programs. You will actively support clinical development activities, operating cross-functionally by engaging with the diverse teams across Bicycle including, but...

Job Description About the role: The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the neuromuscular and rare disease...

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....

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...

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...

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...

Beam is seeking a highly energetic, talented and motivated Regulatory co-op to join our growing Regulatory team from July through December 2024. The Regulatory Affairs co-op will support the Regulatory Affairs team by performing research for regulatory intelligence, summarizing guidances, and maintaining trackers. The candidate will gain experience in...

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...

Regulatory Labeling Strategy100 % Remote - must work EST hoursMax PR: $165 an hourProvides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP).Ensures that there is...