- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you...regulatory strategies, submissions and approvals for assigned biosimilar project (s) + Interface with project teams and… more
- Boehringer Ingelheim (St. Joseph, MO)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/ Associate Director , Regulatory Affairs Pharma Safety & Efficacy ... with more senior RA team members to provide consistent regulatory advice to project teams regarding the...to handle high workloads and understanding of cultural differences. ** Associate Director - Additional Requirements** + Advanced… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to...maintain tracking and archiving of approved labels . Develop project timelines and manage labeling projects from initiation to… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Regulatory Affairs...focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in ... regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...Own the preparation of major clinical submissions required for regulatory approval. + Work with project teams… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs, you will be responsible for managing a team that develops and executes the strategy ... with Legal and clinical team to ensure compliance with regulatory requirements. + Presents regulatory project updates, risks and regulation or guidance… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs, Strategic Global Labeling, combines ... label language based on competitive knowledge and knowledge of project data. + Works cross functionally with teams such... labeling environment. + Under the direction of the Director , Global Labeling, provides regulatory leadership and… more
- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Associate Director Regulatory Affairs** will work on-site at ... Vascular Division. As a manager, the function of an Associate Director Regulatory Affairs is...produce and market new products. + Provides guidance on regulatory requirements and strategies to product development project… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs, Strategic Global Labeling - ... Combination Products and Devices, combines the knowledge of scientific, regulatory , and business issues to support labeling for products that are developed,… more
- Gilead Sciences, Inc. (Boston, MA)
- …and career interests. Position will be filled as a Senior Manager or Associate Director , based on candidate experience. **REQUIREMENTS:** We are all different, ... Join Gilead and help create possible, together. **Job Description** Job Description Regulatory Affairs Labeling is a core function within Gilead's Global … more
- Boehringer Ingelheim (Ridgefield, CT)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , Global Regulatory Affairs Analytics and Performance ... is dedicated to strategically aligning Global Regulatory Affairs (GRA) objectives for all functions with quantifiable performance indicators, spearheading… more
- Novo Nordisk (Princeton, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director , Global Regulatory Portfolio Lead. Essential Functions + Serve as ... Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational...a member of the Global Project Team (GPT) utilizing precedent and experience to develop… more
- Sanofi Group (Bridgewater, NJ)
- …standardized methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core ... team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
- Sanofi Group (Bridgewater, NJ)
- …standardized methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core ... **Main responsibilities:** + Leads the US regulatory activities. + As a key member of...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …on new marketing concepts, messaging, and campaigns. + Represents RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings ... direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Project Scientist (Oncology) - 2406181923W **Description** At Johnson & Johnson, we believe health is everything. Our strength ... Learn more at https://www.jnj.com/ . Johnson & Johnson is recruiting for an Associate Director , Clinical Project Scientist, Oncology. The position can… more
- Merck (North Wales, PA)
- … Management Office (PMO), and Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member ... the R&D pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- CSL Behring (King Of Prussia, PA)
- …position is located in our King of Prussia PA office. It is a Hybrid role. The Associate Director , R&D Project Planning Capability Lead, is a member of CSL ... on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Associate Director , R&D Master Scheduling Lead? This… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 serve as an...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Scientific Associate Director , DMPK Project Representative** Challenging. ... across the globe. PCO is looking for a Scientific Associate Director to join the Dev DMPK...will represent the Dev DMPK function on cross-functional development project teams; oversee developmental drug disposition metabolism and non-clinical… more
- Merck (West Point, PA)
- **Job Description** **Position Description:** ** Associate Director , Project Management** As an Associate Director in the Nonclinical Drug Safety ... NDS and associated study scheduling systems. + Interfacing with Operations - Project Planning (NDS) and impacted laboratory/operational areas on changes in study… more