- 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
- Danaher Corporation (Raleigh, NC)
- …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
- 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 + Experience in … more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, ... GRS, is responsible for the management of global regulatory leads with product and disease...may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures… more
- Gilead Sciences, Inc. (Foster City, CA)
- …co. Gilead is a patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and Analytics this ... not limited to: + Partner with stakeholders (eg, Medical Affairs , Business Conduct, Development, Regulatory Affairs...advise in cross functional governance, standards and SOPs for global MA digital assets and capabilities + Lead digital… more
- Lilly (Indianapolis, IN)
- …right patient using model-informed drug research and development (MIDD). We are seeking a Senior Director to lead a group of PKPD Project Leaders in advancing ... standards and streamline business practices. + Review and approve PK/PD global regulatory submissions and responses, Tox/Drug Disposition/PKPD or Clinical… more
- J&J Family of Companies (Raritan, NJ)
- …impact health for humanity. Learn more at https://www.jnj.com/. The Senior Director , Global Medical Affairs Operations Excellence will report directly ... Strategy and Execution - Oncology and supporting the Vice President of Global Medical Affairs - Oncology. The Senior Director will play a critical role… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... where you will oversee the development and execution of regulatory CMC development and registration strategies. RA ...Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs...Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is responsible for leading ... global portfolio of biological products in CMC Regulatory Affairs . This position will provide leadership...(Biologics) submissions, and "right to operate" by maintaining the global licensures. In addition, the Sr Director … more
- Takeda Pharmaceuticals (Lexington, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will ... assigned products. RA CMC member on the Global Regulatory CMC team. Serve as or...Regulatory CMC team, you will report to a Senior Director and work with stakeholders across… more
- J&J Family of Companies (Skillman, NJ)
- Senior Associate , Regulatory Affairs - 2407025090W **Description** Kenvue is currently recruiting for: Senior Associate, Regulatory Affairs , ... Supplements This position reports to the Director , Regulatory Affairs and is based in Skillman....<10% **Pay: 84k- 152k** **What you will do** The Senior Associate, Regulatory Affairs is… 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 ... strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory ...+ Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience:… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory ... employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be...Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and… more
- Ascendis Pharma (Palo Alto, CA)
- … information to project teams. + Works independently with directional support from a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a ... of the business, from drug development to marketing. The Senior Manager, Regulatory Affairs will...Affairs will be responsible for supporting and developing global regulatory strategies for the oncology pipeline… more
- J&J Family of Companies (Skillman, NJ)
- …Director , Regulatory Affairs , Dietary Supplements This position reports to the Senior Director , Regulatory Affairs and is based at Skillman, ... For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX\_M) . **Role reports to: Senior Director , RA Self Care** **Location:** Summit,… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …Become a **maker** **of possible** with us. **About the role:** Reporting to the Director of Regulatory Affairs , responsible and accountable for developing ... and for to cross-functional groups across BD. + Provides recommendations for BDDS Regulatory Affairs functional budget. **About you:** + Ability to think… more
- ADM (Kennesaw, GA)
- …in the North American Market. The Senior Manager works in conjunction with the Global Director or Regulatory Compliance H&W and the Director of ... **83651BR** **Job Title:** Senior Regulatory Affairs Manager...the products in the market **Job Responsibilities:** + Leverage global regulatory compliance of the H&W portfolio… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more