- Gilead Sciences, Inc. (Foster City, CA)
- …processes, tools, team, and other capabilities. **EXAMPLE RESPONSIBILITIES:** + Leads the Regulatory Affairs Data Governance Council and drives the ... a comprehensive data governance framework that is fit for purpose for Regulatory Affairs data and processes. + Accountable for driving an effective and… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products...objectives in the context of available and expected scientific data , regulatory guidance, and precedent + Lead… more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products...regulatory direction in the development of the core data sheet to align commercial objectives in the context… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and Controls (CMC) ... marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research &… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia...agencies and trade associations and provide executive management with regulatory metrics/information. The individual may ensure that data… more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising… more
- Chemours (Wilmington, DE)
- …improvement at a time. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing **Government Affairs ** team! This position ... Group with a primary responsibility for supporting US federal regulatory affairs engagement with the United States...as well as internal equity, and alignment with market data . The incentive pay is dependent on business results… more
- Sumitomo Pharma (Columbus, OH)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/ data ) and contributes to content as needed + Advises… more
- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of Quality ... the organization. The Senior Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading, and executing large scale… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... transparent ways of working across the Alliance within US regulatory affairs and will work closely with...within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings. + Strategize and… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... + Lead functional groups in the development of relevant data to complete a regulatory submission. +...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …will provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and play a ... and multicultural environment and leverages their extensive experience to represent regulatory affairs in discussions with external and internal stakeholders.… more
- Merck (Columbus, OH)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices...are presented clearly, and conclusions are adequately supported by data . + Superior oral and written communication skills in… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Independently ... within the organization. + Lead team members that defines CMC content ( data and documentation) requirements for regulatory submissions and reviews this… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC ... a site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science, collaborates with product development, manufacturing… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …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 ... responsibilities. + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing… more
- Charles River Laboratories (Northridge, CA)
- …at Cell Solutions, you will make a difference every day. **Job Summary** The Director , Regulatory Affairs and Quality Assurance is responsible for ensuring ... department. * Review SOPs and policies to ensure compliance with applicable regulatory requirements to assure that products have the safety, quality, identity,… more
- The Coca-Cola Company (Whitestone, NY)
- …food science or relevant science discipline required. **Job Description Summary** : The Director , Scientific and Regulatory Affairs Compliance and Innovation ... develops, improves, and drives compliance to all Regulatory requirements at BODYARMOR. In addition, this role also manages supplier quality. This person will be a… more
- Takeda Pharmaceuticals (Columbus, OH)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... EU MDR and IVDR. + Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge… more