Senior Director Regulatory Affair jobs
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SENIOR DIRECTOR, REGULATORY AFFAIRS CMC , INNOVATIVE MEDICINE (HYBRID)
Influence the strategy and assess the quality of documents for regulatory submissions to major market health authorities as well as coordinate with global regulatory colleagues to prepare dossiers for global registration.. Ident...
| Company | Teva Pharmaceuticals |
|---|---|
| Address | West Chester, PA |
| Category | Information Technology |
| Date Posted | a month ago See detail |
Senior Director, Regulatory Affairs CMC , Innovative Medicine (Hybrid)
Teva Pharmaceuticals
West Chester, PA
Influence the strategy and assess the quality of documents for regulatory submissions to major market health authorities as well as coordinate with global regulatory colleagues to prepare dossiers for global registration.. Ident...
a month ago seen See more...
Senior Director, Regulatory Affairs II
Teva Pharmaceuticals
West Chester, PA
Manage resources to support submission activities for responsible sites and oversees the coordination and delivery of major submissions to directly support the companies growth strategy. Build relationships with RA staff/authorin...
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Senior Director, Regulatory Affairs
Alx Oncology Inc.
South San Francisco, CA
Providing dynamic regulatory leadership and guidance to project teams and working collaboratively with cross-functional team members, external contractors, vendors and consultants to identify optimum and effective regulatory strat...
2 months ago seen See more...
Senior Director, Global Regulatory Strategy, Therapeutic Area Lead
Biogen
Olin, NC
15+ years of experience in drug development and regulatory affairs in the biotechnology or pharmaceutical industry. 5 years of leadership experience in a regulatory affairs management role. In depth and relevant Global regulatory...
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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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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...
3 days ago seen See more...
Senior Director, Cellular Therapy Patient & Professional Relations, Public Affairs
Biospace
California, United States
Serve as a strategic business partner and advisor to Commercial and R&D teams, leveraging advocacy expertise, business acumen and interpersonal skills to bring the voice of the patient to Kite's planning and programming. Manage ke...
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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...
5 days ago seen See more...
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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...
7 days ago seen See more...
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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...
7 days ago seen See more...
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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...
7 days ago seen See more...
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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...
7 days ago seen See more...
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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...
7 days ago seen See more...
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Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Biospace
Washington, DC
To lead GRTs within Amgens GRAAS organization. To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes...
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Senior Director, Regulatory Information Management
Biospace
Waltham, MA
Develop and implement the strategy for Regulatory Information Management including processes and optimization of systems. Develop and implement the strategy for operationalizing simultaneous marketing application filings in multip...
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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...
2 weeks ago seen See more...
Senior Advisor/Director, Global Regulatory Affairs – CMC
Biospace
Indianapolis, IN
Deep technical knowledge of synthetic molecule CMC drug development science(s). Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations. Development...
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- View all Biospace jobs - jobs in Indianapolis, IN
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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Senior Director, Global Regulatory Intelligence & Policy
Biospace
Basking Ridge, NJ
Leads day-to-day a team of Regulatory Intelligence Policy professionals across all major regions, incl. mentorship, performance mgmt., etc. Supports the team in both Regulatory Intelligence (collection, interpretation and communic...
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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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Director, Regulatory Affairs Strategy, Hematology
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...
2 weeks ago seen See more...
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Director, Regulatory Affairs Strategy, Hematology
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...
2 weeks ago seen See more...
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Director Regulatory Affairs
Nikang Therapeutics Inc
Wilmington, DE
Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings. Lead multidisciplinar...
2 weeks ago seen See more...
Senior Director– Global Medical Affairs, Lilly Diabetes and Obesity
Biospace
Remote - Indiana, United States
Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implem...
2 weeks ago seen See more...
- View all Biospace jobs - jobs in Indiana State
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