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SENIOR DIRECTOR/DIRECTOR, GLOBAL REGULATORY AFFAIRS EARLY RESPIRATORY & IMMUNOLOGY
Work on cross-project initiatives of high importance for the early R&I portfolio. Lead the development and implementation of innovative global strategies of increasing complexity to improve the likelihood of regulatory success. Ac...
| Company | Astrazeneca |
|---|---|
| Address | Boston, MA |
| Category | Sales/marketing |
| Date Posted | a week ago See detail |
Senior Director/Director, Global Regulatory Affairs Early Respiratory & Immunology
Astrazeneca
Boston, MA
Work on cross-project initiatives of high importance for the early R&I portfolio. Lead the development and implementation of innovative global strategies of increasing complexity to improve the likelihood of regulatory success. Ac...
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Senior Product Stewardship & Regulatory Affairs Specialist Job New
Arkema
United, PA
Prepare and maintain commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for...
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Senior Director, Public Affairs New
Biospace
Washington, United States
Develop and lead environment crafting communications campaigns and activities for priority policy goals with GPP, Legal, FGA, LVA and the BUCAs. Collaborate with partners within Global Corporate Communications, (Corporate Channe...
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Medical Affairs-Scientific Director CV Renal New
Biospace
Plainsboro, NJ
Identify and anticipate potential trends, changes to market conditions and areas of opportunity aligned with Therapeutic Area priorities. Utilizes subject matter expertise and analytical tools to provide deeper customer knowledge...
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Associate Director, Regulatory Affairs Innovation
Biospace
Irvine, CA
Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...
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Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination
Biospace
North Chicago, IL
Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...
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Regulatory Affairs Director, Oncology
Astrazeneca
Waltham, MA
Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.. Develop and implement the program's regional or global strategy ensuring tha...
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Director, Clinical Regulatory Affairs
Cymabay Therapeutics
Newark, CA
Work with Vice President to devise regulatory strategies to ensure rapid and timely approval of products. Develop global regulatory plans to facilitate the progress of programs in all phases of development. Identify risk mitigatio...
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Senior Manager/Associate Director of Regulatory Affairs
Tempus
Chicago, IL
Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...
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Director, CMC Regulatory Affairs Biologics
Biospace
California, United States
Lead CMC regulatory strategy for a single or multiple products. Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of pro...
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Director, Global Regulatory Affairs (GRL)
Biospace
Basking Ridge, NJ
Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products. Seeks and incorporate regional and functional RA strategy into a global strate...
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Associate Director, US Regulatory Affairs Strategy
Daiichi Sankyo, Inc.
Basking Ridge, NJ
Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...
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Director, Science & Regulatory Affairs
Biotechnology Innovation Organization
Washington, DC
Excellent communications skills, including writing and speaking skills Background in biology, drug development, and the life sciences Excellent research skills, including problem-solving ability and attentiveness to detail Ability...
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Director of Regulatory Affairs
University Of Advancing Technology
Tempe, AZ
Routinely review documents and conduct quality checks while verifying compliance and regulatory mandates are met. Develop and execute regulatory strategies to support product development, registration, and commercialization plans....
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Associate Director, Regulatory Affairs - Remote OR West Chester, PA
Teva Pharmaceuticals
West Chester, PA
Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...
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Director, Regulatory Affairs
Byheart
New York, NY
The only U.S.-made infant formula to use organic, grass-fed whole milk. The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk-alpha-lac and lactoferrin-to our ingredients list. T...
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Sr. Director, Regulatory Affairs
Biospace
San Diego, CA
Develop, implement and maintain regulatory and quality assurance strategies and activities for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs Advertising and Promotion
Biospace
California, United States
Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director - Regulatory Affairs - AD Promo
Biospace
Princeton, NJ
Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...
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Director Regulatory Affairs
Paysafe
Jacksonville, FL
Bachelor's degree; advanced degree preferred. Minimum of 8 years of experience in Regulatory Affairs, compliance, or legal roles within the financial services industry, with a focus on payments, fintech, or e-commerce. Strong unde...
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Director Regulatory Affairs - Submission Management - West Chester, PA
Teva Pharmaceuticals
West Chester, PA
Responsible to manage Product Submission Team and dossier timelines. Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management. Regularly reports to management on progr...
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Director, Regulatory Affairs, Oncology - Job ID: 1311
Ascendis Pharma
Palo Alto, CA
Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance. Life Insurance (Basic, Voluntary & AD&D)....
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Director Regulatory Affairs *Remote*
Providence
Beaverton, OR
Be responsible for managing and developing a team tasked with performing regulatory consulting and regulatory product lifecycle support for all Providence Health Plan and Providence Health Assurance business activity and strategic...
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