- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global CMC** **What you will do** Let's do ... and execution of strategy by the CMC and Device Regulatory Affairs team for Obesity and Obesity...(US, EU, Japan and China) + In-depth knowledge of global CMC regulations and understanding of evolving challenges and… more
- AbbVie (Irvine, CA)
- …you will be added to our talent pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, ... offices, or North Chicago, IL offices. + Responsible for leading the Global Regulatory Product Team (GRPT), developing, and implementing global strategies to… more
- Danaher Corporation (Chicago, IL)
- …Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs will be responsible for developing and executing ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...ensuring accuracy, completeness, and timeliness. + Monitor and interpret global regulatory requirements and trends, provide strategic… more
- Herbalife (Torrance, CA)
- Director , Global Regulatory Affairs - Corporate Category: Legal Position Type: Regular Full-Time External ID: 14913 Location: Torrance, CA, United States ... to linkedin Apply Now **Overview** **THE ROLE:** Reporting to the VP of Global Regulatory & Post-market Safety Affairs , this individual will be responsible… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in 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
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **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 years of related experience.… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory Forum (GRF), Executive Labeling Committee (ELC), Steering… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures… 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 ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- AbbVie (Pleasanton, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director of Regulatory Affairs - Body Contouring and ... and strategy (eg, Medical Device Regulation) for medical devices to support global regulatory plans, due diligence, integrations, and divestitures. Acts as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …7 or More Years in the pharmaceutical industry preferred + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA preferred **Travel:** + Ability to ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory guidance to ... and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Lilly (Indianapolis, IN)
- …for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs , Global Regulatory ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participatein… more
- J&J Family of Companies (Trenton, NJ)
- …(GRL) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader located in New ... Director , Global Regulatory Leader...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs leader for the Infusion Process Excellence RA ... regulators. This position provides expertise and leadership to business partners, the Assoc Director of Process Excellence Regulatory Affairs , and execute … 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
- Gilead Sciences, Inc. (Foster City, CA)
- …liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. ** Director , CMC Regulatory Affairs - Biologics** **Key ... Responsibilities:** The Director , CMC Regulatory Affairs for Biologics is responsible for...degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... of current global and regional trends in regulatory affairs and ability to assess the...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more