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Intellia Therapeutics, Inc.
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determin
Job Source: Intellia Therapeutics, Inc.Intellia Therapeutics, Inc.
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determ
Job Source: Intellia Therapeutics, Inc.Vertex Pharmaceuticals
Boston, MA, United States
Director, Regulatory Strategy page is loaded Director, Regulatory Strategy Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-22162 Job Description The Regulatory Strategy Director will be responsible for the development and implementation of innovative global/regio
Job Source: Vertex PharmaceuticalsVertex Pharmaceuticals
Boston, MA, United States
Associate Director, Regulatory Strategy page is loaded Associate Director, Regulatory Strategy Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-22153 Job Description The Regulatory Strategy Associate Director will be responsible for overseeing the development of r
Job Source: Vertex PharmaceuticalsThe Newsome Group
Lexington, MA, United States
The Executive Director will be responsible for developing and implementing global regulatory strategy leading to successful registration and life-cycle management. This individual will provide regulatory leadership to cross-functional teams responsible for global programs and ensure effective communication with business partners and representatives
Job Source: The Newsome GroupKinsley Power Systems
Cambridge, MA, United States
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 bond
Job Source: Kinsley Power SystemsProclinical Staffing
Boston, MA, United States
Director of Global Regulatory Strategy - Permanent - Boston, Massachusetts MA Proclinical is seeking an individual experienced in Global Regulatory Strategy. This is a temporary contract position which holds a hybrid working module and is based in Boston, Massachusetts. Primary Responsibilities: This role is perfect for an individual who thrives
Job Source: Proclinical StaffingAgios Pharmaceuticals
Cambridge, MA, United States
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
Job Source: Agios PharmaceuticalsCambridge, MA, United States
Join this company in a pivotal role where your expertise will advance our mission of utilizing innovative science to develop impactful cancer treatments. This position offers the chance to influence and drive regulatory strategies that align with our cutting-edge oncology assets, fostering collaboration with the FDA to expedite the development and approval of new therapies.
Key Responsibilities:
Regulatory Strategy Development : Formulate and implement US regulatory strategies for assigned projects, ensuring alignment with overall development plans. Prepare for and strategize FDA meetings.
FDA Liaison : Serve as the primary point of contact with the FDA. Lead negotiations, organize meetings and teleconferences, and maintain effective communication channels.
Submission Management : Oversee and prepare FDA submissions, including briefing documents, breakthrough therapy designation requests, and orphan drug applications.
Global Project Collaboration : Participate in global project team meetings for both development and marketed products, providing regulatory guidance and managing daily regulatory activities. Collaborate across all disciplines within the organization to gather necessary information for regulatory filings.
Regulatory Representation : Potentially serve as the sole regulatory representative on study teams, offering expert guidance.
Guideline Review and Interpretation : Stay informed of and interpret relevant regulatory guidelines to ensure compliance and strategic alignment.
Continuous Learning : Keep abreast of regulatory updates by attending relevant meetings, seminars, and conferences, and by engaging with scientific literature and other resources.
Qualifications:
Education :
Bachelors Degree (required)
Advanced degree (e.g., Masters, PharmD, Ph.D., MD, JD) (preferred)
Experience :
10+ years in the pharmaceutical industry
8+ years in regulatory affairs
Proven experience in providing strategic regulatory input throughout the drug development process, with comprehensive knowledge of IND and NDA/BLA processes.
Familiarity with US pharmaceutical regulations and global regulations (such as ICH) is highly desirable. Experience with (s)NDA/BLA filings to the FDA is a plus.
Competencies:
Communication : Excellent oral and written communication skills, strong interpersonal skills, and the ability to thrive in a team environment.
Stress Management : Ability to perform effectively in high-pressure, deadline-driven situations.
Motivation and Multi-tasking : Energetic, self-motivated, and adept at handling multiple tasks simultaneously.
Organizational Skills : Proactive, disciplined, and detail-oriented, with a keen eye for detail.
Analytical Thinking : Ability to think logically and objectively, identifying significant problems and opportunities.
Travel:
Ability to travel up to 30% for this in-house position, which may include occasional global travel.
Email Alert for Director Regulatory Strategy jobs in Cambridge, MA, United States
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