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Proclinical Staffing
Boston, MA, United States
Regulatory Affairs Director - Permanent - Boston, MA Proclinical is seeking a Regulatory Affairs Director who will be responsible for the development and execution of regulatory strategies for assigned programs. This is a permanent position based in Boston, MA. Primary Responsibilities: The successful candidate will work collaboratively with variou
Job Source: Proclinical StaffingApellis Pharmaceuticals
Waltham, MA, United States
Position Summary: The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for accountable program(s). Key Responsibilities Include: Ensure alignment of global regulatory strategies with Apellis corporate objectives. Collaborate
Job Source: Apellis PharmaceuticalsDyne Tx
Waltham, MA, United States
Our commitment to people with muscle diseases Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitati
Job Source: Dyne TxPAREXEL
Billerica, MA, United States
Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product app
Job Source: PAREXELThe Steely Group
Cambridge, MA, United States
The Director, Regulatory Affairs will serve as a Health Authority liaison and Regulatory Project Leader for our clients multiple projects in various stages of development. This individual will establish and communicate regulatory strategies and mana Regulatory Affairs, Director, Regulatory, Leader, Product Development, Project Lead, Business Servic
Job Source: The Steely GroupPAREXEL
Billerica, MA, United States
Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product app
Job Source: PAREXELBiofourmis
Needham Heights, MA, United States
The Director of Quality and Regulatory Affairs is responsible for developing and implementing the long range regulatory and compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis remote patient monitoring platforms and pharma partnerships on a global basis. Reporting
Job Source: BiofourmisRapport Therapeutics
Boston, MA, United States
As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition
Job Source: Rapport TherapeuticsCambridge, MA, United States
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 define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the global regulatory lead on relevant project teams to formulate and execute development strategies for developmental programs. You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions. You will be coaching and mentoring junior regulatory staff to support their development and enable program deliverables.
Your Role:
You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
You will be responsible for leading the preparation and submission of high quality domestic and global regulatory submission documents (i.e. IND, CTA, NDA/MAA), as well as leading the development of response strategies to regulators.
You will be responsible for communicating with the global regulatory authorities and leading the preparation and conduct of meetings with health authorities, which includes the development of robust briefing packages and comprehensive meeting preparation to maximize outcomes of meetings.
You will be responsible for integrating your knowledge of current legislation, guidelines and other regulatory intelligence into the development strategies and ensuring compliance with regulatory filing and reporting requirements.
You will be responsible for proactively identifying regulatory opportunities and risks and proposing alternative approaches and mitigations to resolve development program challenges.
You will lead the efforts to plan and obtain regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations and contribute to the CDx strategy development and submissions.
You will provide oversight to the global regulatory activities that are performed by our Clinical Research Organization (CROs) and regulatory vendors.
You will lead and mentor junior staff in the regulatory team to support their development and enable program deliverables.
Your Background: You have earned your B.S and/or M.S. and bring at least 5 years of increasing responsibility in regulatory affairs. Advanced degree or education in a scientific field is a plus.
You are results-oriented and have comprehensive knowledge of the drug development process and have a demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc.)
Experience in precision oncology, rare disease and/or companion diagnostic (CDx) is a plus.
You are a regulatory interpreter; you have experience in interpretation of regulations, guidelines, and policy statements and know how best to exercise regulatory flexibility.
You are a strategic thinker, capable of proposing innovative solutions to regulatory problems.
You have strong verbal and written communication skills, including the ability to present strategic topics/issues to project teams, management and regulatory agencies.
Self-motivated and driven with a proactive and flexible working style with a passion for impacting patient's lives through regulatory work.
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About Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.
Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!
Email Alert for Director, Regulatory Affairs jobs in Cambridge, MA, United States
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