- Amgen (Washington, DC)
- …this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area. Global Regulatory ... It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology ** **Live** **What you will do**… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- 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
- CVS Health (Sacramento, CA)
- …CVS Health, a Fortune 6 company, has an outstanding opportunity for a Medical Director - Medical Affairs . We need a Double Board Certified Oncologist/Internal ... product development, Enterprise Analytics, Compliance, Legal, Accreditation) and clients. The Medical Director (Medical Affairs ) will report into the Medical … more
- AbbVie (Mettawa, IL)
- …title will be based on qualifications listed below. + Generate and lead Medical Affairs strategies for genitourinary (GU) oncology pipeline + Initiates medical ... discovery, statistics, regulatory , etc) as they relate to on-going Medical Affairs projects. Serves as the scientific team interface for key regulatory … more
- Bayer (Whippany, NJ)
- …brilliant and diverse minds to make a real difference, there's only one choice.** ** Director , Medical Affairs Communications Oncology ** The Director , ... as needed. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director , Medical Affairs Communications Oncology , are to: +… more
- AbbVie (Waltham, MA)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... preferred. Will consider remote candidates. Purpose: The Associate Medical Director /Associate Scientific Director provides specialist medical/scientific strategic… more
- AbbVie (Irvine, CA)
- …defines quality objectives, both strategic and applicable regulatory requirements. Director , Safety, Regulatory and Medical Affairs Quality Standards ... responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs...assurance excellence mindset. The role reports to the Senior Director of Safety, Vigilance and Medical Affairs … 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
- Amgen (Thousand Oaks, CA)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global CMC** **What you will do** ... toughest diseases. With our focus on four therapeutic areas - Oncology , Inflammation, General Medicine, and Rare Disease- we reach...and execution of strategy by the CMC and Device Regulatory Affairs team for Obesity and Obesity… 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with direct regulatory affairs experience, including experience in regulatory submissions in Oncology + Managerial experience + Experience with ex-US ... for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US,...the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project… more
- BeiGene (San Mateo, CA)
- …met while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the solid tumor ... The Executive Director , Solid Tumor North America Lead will be...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… 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
- BeiGene (Emeryville, CA)
- **General Description:** Reporting to the Head of Regulatory , Advertising/Promotion, this role provides regulatory oversight, and strategic guidance on ... marketed products in North America. This role supports our commercial, medical affairs , legal, healthcare compliance and other business functions in the United… more
- AbbVie (North Chicago, IL)
- …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
- AbbVie (Pleasanton, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director of Regulatory Affairs - Body Contouring and ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...Regulatory Innovation MPS supports regulatory objectives for the company's Body Contouring devices for… more
- AbbVie (Irvine, CA)
- …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
- 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