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Actalent
Boston, MA, United States
Description: Developing and implementing global and/or US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. Skills: Regulatory affairs, regulatory strategy, Fda, Regulatory submission Additional Skil
Job Source: ActalentProclinical 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 StaffingVertex 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: MeetIntellia Therapeutics, Inc.
Cambridge, MA, United States
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Job Source: Intellia Therapeutics, Inc.Intellia Therapeutics, Inc.
Cambridge, MA, United States
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Job Source: Intellia Therapeutics, Inc.Meet Recruitment
Cambridge, MA, United States
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Job Source: Meet RecruitmentBioSpace, Inc.
Cambridge, MA, United States
Job Details The Role: Moderna, Inc. is seeking a Director of Regulatory Strategy to develop and lead global strategy for mRESVIA, Modernas late stage / marketed RSV messenger RNA (mRNA) vaccine (Adult indication) to be based in one of Modernas East Coast hubs. The Global Regulatory Lead (GRL) role is intended for a forward looking, creative regul
Job Source: BioSpace, Inc.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 in a fast-paced environment and is passionate about developing and implementing regulatory plans for complex products aimed at addressing rare diseases and unmet medical needs. The successful candidate will be a key player in a diverse and ambitious team, contributing to the successful registration and life-cycle management of products.
Skills & Requirements:
Strong knowledge of US drug development and regulatory policy.
Proven knowledge on providing US strategic regulatory advice for the global development of products.
Experience with running submissions and FDA meetings.
Ability to manage complex issues and coordinate multiple projects simultaneously.
Strong interpersonal and written/verbal communication skills.
Proven track record practicing sound judgment as it relates to risk assessment.
Highly conversant and knowledgeable of new and emerging regulations and guidances.
Bachelors Degree in a related discipline.
The Director of Global Regulatory Strategys responsibilities will be:
Develop and direct innovative regulatory strategies for specific projects and across projects in our portfolio.
Serve as the global or US Strategy lead on assigned programs.
Provide advice on regulatory issues for both marketed and pipeline products.
Represent the company as the point of contact with the FDA and lead the company delegation for regulatory authority meetings.
Lead US submissions to regulatory authorities in support of proposed and ongoing development programs.
Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies.
If you are having difficulty in applying or if you have any questions, please contact Kylie Williams at (+1) 267 523 2542 or [email protected] .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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Email Alert for Director, Global Regulatory Strategy jobs in Boston, MA, United States
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