Sr. Director of Regulatory Affairs
3 weeks ago
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, and facilitating communication with regulatory authorities. This role will also navigate the regulatory landscape and ensure compliance with regulatory requirements.
What you would be responsible for:
- Lead and support preparation of high-quality global regulatory submissions including IND applications to support early-stage clinical development activities.
- Provide input into the design of clinical trial protocols to ensure they meet regulatory requirements.
- Review and approve protocols to ensure they align with the regulatory strategy.
- Establishing and maintaining effective communication with regulatory agencies.
- Coordinate key interactions with health authorities and facilitate communication of feedback to internal program and clinical development teams.
- Function as regulatory representative on cross functional program teams and meetings with external partners such as CROs.
- Work closely with program teams to ensure timely execution of regulatory milestones.
- Anticipate potential challenges in obtaining regulatory approval and developing strategies to mitigate these risks.
What experiences we are looking for:
- Bachelors degree in a scientific discipline; Advanced degree preferred.
- Minimum of 7 years of experience in regulatory affairs within the biotech/pharmaceutical industry. Biotech experience preferred.
- Demonstrated experience in authoring and preparing IND submissions.
- Experience as primary regulatory author for IND and CTA documents
- Strong knowledge of US and EU regulations and guidelines pertaining to the conduct of investigational drug studies; further global experience would be a plus.
- Experience managing external teams at CROs and driving execution against key deliverables.
- Ability to work across a number of disease areas.
- Excellent communication skills with the ability to collaborate effectively across functions.
- Ability to be on-site at least 3 days a week strongly preferred.
What sets you apart:
- Regulatory experience and knowledge across various therapeutic areas.
- Strong collaborator with multi-disciplinary teams
- Creative problem-solving and critical thinking capabilities
-
Regulatory Affairs Manager
2 days ago
Cambridge, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: 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,...
-
Senior Manager, Regulatory Affairs
3 weeks ago
Cambridge, United States Editas Medicine Full timeJob 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....
-
Director, Regulatory CMC
4 weeks ago
Cambridge, United States Editas Medicine Full timeAt 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...
-
Director, Regulatory CMC
3 weeks ago
Cambridge, United States Editas Medicine Full timeJob 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....
-
Senior Manager, Regulatory Affairs
3 weeks ago
Cambridge, United States Relay Therapeutics Full timeThe 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...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Cambridge, United States Validation Associates Full timeContract 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...
-
Regulatory Affairs Manager III
2 days ago
Cambridge, United States The Fountain Group Full timeThe 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...
-
Senior Manager, Regulatory Affairs
3 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt 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...
-
Senior Manager, Regulatory Affairs CMC
1 week ago
Cambridge, United States Sarepta Therapeutics Full timeThe 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...
-
Director, Regulatory CMC
4 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt 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...
-
Cambridge, United States Beacon Therapeutics (USA) Inc Full timeJob 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...
-
Associate Director or Director Medical Affairs
7 hours ago
Cambridge, United States Beacon Therapeutics (USA) Inc Full timeJoin our team based in Cambridge, MA, and lead pioneering projects in biotech that make a real difference in people's lives. You will receive great benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, Paid Time Off, Employee Discounts, and Employer paid STD/LTD. Be part of a...
-
Regulatory Affairs Executive Assistant
4 days ago
Cambridge, Massachusetts, United States Philips Full timeIn 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...
-
Co-op, Regulatory
4 weeks ago
Cambridge, United States Beam Therapeutics Inc. Full timeBeam 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...
-
Sr Director/Director, Alliance Management
1 week ago
Cambridge, Massachusetts, United States Fulcrum Therapeutics Full timeCompany Overview Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and...
-
Sr. Manager, Regulatory Project Management
7 days ago
Cambridge, Massachusetts, United States Proclinical Full timeSenior 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...
-
Quality Engineer, Sr. Design Quality Engineer
4 weeks ago
Cambridge, United States Gilder Search Group Full timeFor over twenty-five years Biomedical Resource Consultants’(BRC) president David Leo has been an active leader in the MedTech community. Whether helping solve complex technical challenges by matching top talent to myriad MedTech clients; providing leadership and education as chair of the RAPS Boston Chapter or the Biomedical Division of the American...
-
Faculty Affairs Administrator
2 weeks ago
Cambridge, United States Massachusetts Institute of Technology Full timeFACULTY AFFAIRS ADMINISTRATOR, School of Science (So. S), to administer and implement operational and administrative activities for the So. S Dean's Office (DO) faculty affairs program and serve as an expert resource on faculty affairs-related polici Faculty, Administrator, Operations, Education, Program
-
Director Program Management
7 hours ago
Cambridge, United States QurAlis Full timeTitle: Program Team Lead (Director/Sr. Director) ABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS),...
-
Senior Director, GCP Quality Assurance
2 weeks ago
Cambridge, United States Scholar Rock Full timeScholar 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 (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...