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...diversified, unmet medical needs of people globally by leveraging our world-class science... ...Responsible for leading and developing global regulatory strategy for assigned development... ...5 years of experience within Regulatory Affairs
+ Knowledge of IND, NDA/BLA submission...
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...Summary
This position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing...
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...As a Director, Global Regulatory Affairs, Precision Medicine you will develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across the Gi Regulatory Affairs...
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...diversified, unmet medical needs of people globally by leveraging our world-class science... ...formulation of strategy for US and/or global regulatory submissions. This position ensures... ...this position interacts with Regulatory Affairs (RA) team members, cross-functional team...
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...diversified, unmet medical needs of people globally by leveraging our world-class science... ...Leadership responsibility for global regulatory strategy to support the development of biomarkers... ...including experience within Regulatory Affairs
~ Understanding of scientific content...
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...Come Join Our Growing Team!
We are looking for a Senior Director - Regulatory Affairs to join our US team. This role is responsible for... ...develop various type of regulatory submission businesses globally. You will also work closely with the clinical development...
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...aspirations. Join Gilead and help create possible, together.
Job Description
Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional...
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...The Director of Pharmaceutical Affairs & Compliance (DPA) is responsible for leading the Biocodex dietary supplements subsidiaries regulatory strategy and ensuring compliance with all relevant laws... ...and supports interactions with global health authorities and corporate...
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Worldwide
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...diversified, unmet medical needs of people globally by leveraging our world-class science... ...leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through... ...will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities...
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...About the Role
The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products... ...and biologics.
Essential Functions
Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional...
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Overview:
The Senior Director, Regulatory Affairs- GDP provides strategic oversight and direction for regulatory activities on a regional and/or global scale. This role entails leading a multidisciplinary team in developing and executing regulatory strategies to advance...
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...related master data for submission to UDI databases.
Complete UDI database submissions (e.g. US GUDID)
Support and advise on regulatory requirements for UDI direct part marking compliance
Assign and maintain the EU Basic UDI for Client portfolio
Provide the...
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...of twelve commercial manufacturing sites globally and the only commercial manufacturing... ...Responsible for maintaining and updating various regulatory databases to ensure accuracy of... ...scientific area (Degree in Pharmacy/Regulatory Affairs is preferred)
~6?8 years experience in...
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...care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.... ...diseases and immune disorders.
**Job Summary:**
The Director, Global Medical Affairs (GMA), Gyn Oncology, under the direction of the Senior Director...
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...more at
Johnson & Johnson is currently seeking a Medical Director, Bladder to join our team in Raritan, NJ. The preferred... ...given to other locations.
The Medical Director, Bladder - Global Medical Affairs Oncology, will be a member of the Global Medical Affairs team...
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Worldwide
...diversified, unmet medical needs of people globally by leveraging our world-class... ...disorders.
Summary
The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for... ....
* 4 or More Years regulatory affairs including filing NDA and sNDA. BLA...
...programs (as needed) with the support of the supervisor. Analyze requirements specified by FDA pertaining to REMS and other patient safety programs. Works closely with Phar Regulatory Affairs, Manager, Regulatory, Operations, Product Development, Skills, Business Services...
...Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid
Duration: 1 year
SHIFT SCHEDULE... ...internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract...
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...The Opportunity
Description
We're looking for a Regulatory Affairs Specialist III , working in Pharmaceuticals and Medical Products... ...award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic...
...address diversified, unmet medical needs of people globally by leveraging our world-class science and... ...and immune disorders.
Summary
The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible...
