- Amgen (Washington, DC)
- …lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead ** **What you will do** Let's do this. Let's ... Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides...Amgen molecules. In this vital, product-facing role you will lead the Global Regulatory Team… more
- Sanofi Group (Bridgewater, NJ)
- …limits of what you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the ... **Job title: Global Regulatory Lead ** +...**Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ...in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global… more
- AbbVie (Irvine, CA)
- …to our talent pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory ... + Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution. + Participate in global ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned...for operational matters. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project. Lead and… more
- ADM (Chicago, IL)
- …is preferred. + Experience: At least 15 years of experiencein both US and global regulatory affairs , particularly in food, feed, or ingredients. Proven ... **90387BR** **Job Title:** Head of Global Regulatory & Scientific Affairs...and Research & Development. **Key Responsibilities:** + Strategic Leadership: Lead the RSA function, developing and implementing strategies that… more
- Danaher Corporation (Chicago, IL)
- …of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs will be responsible for developing and executing ... the groundwork for vital new discoveries worldwide. You will lead the Regulatory Affairs department...ensuring accuracy, completeness, and timeliness. + Monitor and interpret global regulatory requirements and trends, provide strategic… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop ... and lead global strategies to maximize global ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Kelly Services (Sunnyvale, CA)
- …join us as we pioneer progress in the biotechnology realm. **Position title:** Regulatory Affairs Senior Specialist, Global Market Protection **Workplace:** ... Kelly(R) Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year...for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies. The position offers the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT ( Global ... therapeutic area leaders and joint Alliance partners. **Responsibilities:** + Lead a multidisciplinary Global Regulatory ...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. We are seeking an Advisor/Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly ... Clinical Trial Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs in Cambridge, MA with the following ... requirements: Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field plus 7...Advice; Lead the development of high level global regulatory supplemental biologic application sBLA strategy… more
- AbbVie (North Chicago, IL)
- …you will be added to our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles (US and Canada) are: 1. ... for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) &...cross-functional team who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Olympus Corporation of the Americas (Westborough, MA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Respiratory (GLMAR) is a ... application of prior clinical knowledge and medical training to lead internal stakeholders within the Pulmonary therapeutic area while...as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs in the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a ... application of prior clinical knowledge and medical training to lead internal stakeholders within the Gastroenterology therapeutic area while...as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs in the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... Director GRA CMC where you will independently develop and lead the execution of regulatory CMC investigational,...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Amgen (Washington, DC)
- …Regulatory Affairs Director is: + To lead a team within Amgen's Global Regulatory Affairs department + To develop a comprehensive regulatory ... Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides... global regulatory product strategy + Lead Global Regulatory Teams +… more
- AbbVie (Irvine, CA)
- … and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA ... including but not limited to Pharmacovigilance and Patient Safety, Regulatory Affairs and Medical Affairs ...regulatory requirements. Proactively monitor and interpret the external global regulatory environment for regulatory … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Regulatory Affairs + Represents the Platform in interactions/negotiations with global regulatory agencies and Notified Bodies; enables / empowers staff to ... **Job Description Summary** The Sr. Director, Regulatory Affairs is the ranking ...for submissions regulatory bodies + Liaises with global RA lead (s), to ensure strategic alignment… more
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