Regulatory Affairs Manager III

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....

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,...

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...

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 Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA working within a CMC sub-team structure and serving as a member of the GRT. The Senior...

Contract Role: Schedule: It will be on average 20 hours per week, preferably 4 hours a day M-F, but we can be flexible depending on the candidate. -REMOTE- Regulatory Affairs Specialist DS Process Expert with NDA filing experience. May – September (20 hours week) Contractor to support regulatory documentation review for the Drug Substance part of the NDA...

Job DescriptionJob DescriptionAre you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory...

In this role you will be responsible for supporting the Regulatory Affairs Leaders, streamlining communications, facilitating departmental operations and making the environment productive, upbeat, pleasant and efficient. A great number of different administrative tasks and application of people and organizational skills are required.Your role: Support...

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...

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 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...

Co-lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs) for assigned projects. Positively contributes to the regulatory...

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...

Pay 80-85/hour W2. Our company offers our consultants a suite of benefits after a qualification period including health, vision, dental, life and disability insurance. W2 candidates only, C2C not possible for this role. Manager Updates Can be remote but the manager prefers a candidate local to Cambridge, MA as he would like for them to come into the office a...

Pay 80-85/hour W2. Our company offers our consultants a suite of benefits after a qualification period including health, vision, dental, life and disability insurance. W2 candidates only, C2C not possible for this role. Manager Updates Can be remote but the manager prefers a candidate local to Cambridge, MA as he would like for them to come into the office...

Senior Manager, Regulatory Project Management - Contract - Cambridge, MAProclinical is seeking a Sr. Manager, Regulatory Project Manager for a leading pharmaceutical company. This is a contract position located in Cambridge, MA.Primary Responsibilities:The role is focused on R&D project management for late-stage global regulatory filings. The successful...

​Responsibilities:Coordinate and lead internal and external audits, implement and maintain quality assurance programs, policies, processes, procedures and controls ensuring that the performance and quality of the products conform to established standards and agency guidelines.Design, implement, and improve company quality management systems for medical...

Job Description About This Role  This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific antisense oligonucleotide...