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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.Meet Recruitment
Cambridge, 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
Job Source: Meet RecruitmentIntellia 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 PharmaceuticalsMeet
Cambridge, 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
Job Source: MeetVertex 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 PharmaceuticalsKinsley 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 StaffingLexington, 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 of the US Food and Drug Administration/EMA and other Health Authorities worldwide.
This role is based in Lexington, MA and requires 4 days per week onsite.
Relocation Assistance not available.
Responsibilities:
Provide regulatory strategic leadership for drug development projects and life cycle management (LCM), including but not limited, to regulatory submissions to EMA and other Health Authorities worldwide, health authority interactions, and other regulatory requirements in line with corporate objectives and timelines
Serve as an influential and well-respected spokesperson with staff at FDA/EMA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements
Provide de-risking development strategies and evaluating opportunities to accelerate development in a fast-paced environment
Provide leadership, and contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA/EMA and other Health Authorities worldwide in support of INDs, BLAs, MAAs, DMFs, CTRs/CTAs, IMPDs, PIPs, PAERs, amendments, safety reports, and annual updates
Interpret and communicate regulatory expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations
Qualifications:
Requires a minimum of 10 years of experience in Regulatory Affairs within the bio pharmaceutical industry
Master’s Degree required
PharmD or PhD preferred
Strong knowledge of FDA and EU regulations
Prior experience with FDA and EMA required, and success with filing BLAs/NDAs/MAAs desired.
Experience with both early and late-stage drug development desired
Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities
Experience required with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages, pediatric study plans and documents for other regulatory submissions
Experience interacting directly with the FDA/EMA and other health authorities desired
Experience with biologics drug development is desirable; experience in immunology/inflammation is a plus
Familiar with eCTD, e-publishing systems for preparing regulatory submissions a plus
Strategic thinker who can balance near term objectives with long term goals and outcomes
Ability to thrive in a collaborative and fast-paced team environment
Ability to travel up to 10%
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Email Alert for Executive Director Regulatory Strategy jobs in Lexington, MA, United States
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