- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- AbbVie (Mettawa, IL)
- …and product launches) and market access. Responsibilities: + Generate and lead Medical Affairs strategies for GI oncology pipeline + Initiates medical affairs ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- CVS Health (Columbus, OH)
- …Summary** CVS Health, a Fortune 4 company, has an outstanding opportunity for a Medical Director - Medical Affairs . We need a Board Certified Oncologist for this ... product development, Enterprise Analytics, Compliance, Legal, Accreditation) and clients. The Medical Director (Medical Affairs ) will report into the Medical … more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations... oncology company in the role of Associate Director , Regulatory Affairs Operations where ... community we serve. Position Summary: Under the leadership of Regulatory Affairs the incumbent manages global ...regulatory operational activities (except Asia) for all Taiho Oncology , Inc., (TOI) projects, provides strategic regulatory … more
- Amgen (Washington, DC)
- …worldwide. It's time for a career you can be proud of. **Senior Manager, Corporate Affairs - Oncology ** **Live** **What you will do** Let's do this! Let's change ... role Amgen is seeking a Senior Manager of Corporate Affairs to develop and deliver strategic global communications for...portfolio. The Senior Manager will report directly to the Director of Oncology Communications. This position can… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... (SCI), and in high unmet areas in Immunology and Oncology . MTPA is rapidly expanding its operations across all...to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Veterans Affairs, Veterans Health Administration (Lexington, KY)
- Summary The Clinical Pharmacy Specialist ( Oncology ) is responsible for outpatient oncology pharmacy care activities with an extension of services to the ... including Infusion Center activities, Clinical Privileges or Scope of Practice documents in Oncology will be acquired for practice as a provider, as directed by the… more
- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of 8 years of relevant … 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 ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Takeda Pharmaceuticals (Columbus, OH)
- …FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …years with direct regulatory affairs experience + Experience in regulatory submissions in Oncology + Managerial experience preferred + Experience with ... for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US,...product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project… 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 ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for ... labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + ... be preferred but not required. + Experience in providing regulatory strategic input into the Oncology drug...in providing regulatory strategic input into the Oncology drug development preferred. + Ability to interpret and… more
- AbbVie (North Chicago, IL)
- …you will be added to our talent pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, Global ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- Bristol Myers Squibb (Madison, NJ)
- …MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements** ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- AbbVie (South San Francisco, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more