- Bristol Myers Squibb (New Brunswick, NJ)
- …supports Medical Information to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director, ... personal lives. Read more: careers.bms.com/working-with-us . The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lexington, ... guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory ...prescription drug and biologic products. + Provide regulatory strategic oversight for at least one (1) complex… more
- Haleon (Warren, NJ)
- …be to provide a systematic review and categorization of archived Food and Drug Administration (FDA) regulatory correspondences and other documents. This role ... components for both Investigational New Drugs (INDs) and New Drug Applications (NDAs) across the Haleon portfolio. It will...individual contribution at Haleon be?** The expectation for the Regulatory Affairs Associate role will be as… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** Review promotional claims and materials for BI Rx drug promotion for compliance with Food Drug Cosmetic Act (FDCA) and for consistency with ... product labeling. Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications… 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, ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- Capital One (Richmond, VA)
- West Creek 3 (12073), United States of America, Richmond, Virginia Regulatory Reporting Quality Assurance, Principal Associate **Description:** If you're looking ... company and a great place to work. **Team Profile** **:** The Regulatory Reporting Quality Assurance (RRQA) function is responsible for performing independent… more
- J&J Family of Companies (Spring House, PA)
- Associate Director, North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director, ... potential. At Johnson & Johnson, we all belong. The Associate Director, Regulatory Affairs will be responsible...health regulated industry experience. + An understanding of the drug product lifecycle from discovery to clinical trials to… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves ... product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** + Provides regulatory review… more
- Takeda Pharmaceuticals (Columbus, OH)
- …company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - GI2 TAU ... teams and mentoring colleagues. + Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance,… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Salary Range: Dependent on Qualifications/Experience Position Summary/Description: The purpose of the Regulatory Associate Lead is to facilitate the conduct of ... oncology clinical trials by ensuring regulatory compliance with federal regulations, Good Clinical Practice, and...submissions, for: - therapeutic clinical research studies involving a drug or device, and/or - oncology clinical research studies… 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 develop and ... can be considered). + Understanding of scientific principles and regulatory CMC requirements relevant to global drug ...and regulatory CMC requirements relevant to global drug development and post-market support. + Proven ability to… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate 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...project management skills as evidenced by past performance on drug development project teams + Ability to thrive in… 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 ... drug -device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... Join our dynamic and expanding mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations where you will utilize your knowledge… more
- Ascendis Pharma (Princeton, NJ)
- …a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling ... 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)
- …research areas centered around rare diseases and immune disorders. **Job Summary:** The Associate Director of Regulatory Writing is a key role responsible for ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess...and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug … more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC ... radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific CMC regulatory … more
- Bristol Myers Squibb (Princeton, NJ)
- …for the drug development process. + Understanding of general global regulatory requirements for drugs in development. + Understanding of R&D process and specific ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- University of Michigan (Ann Arbor, MI)
- Senior Associate Regulatory Analyst Apply Now **How to Apply** A cover letter is required for consideration for this position and should be attached as the first ... each team member feels respected, valued, and safe. The position of Senior Associate Regulatory Analyst (SARA) is responsible for the highly competent review… more
- Bank of America (Dallas, TX)
- Oil & Gas Regulatory & Research Specialist - SAM Associate II Dallas, Texas **Job Description:** At Bank of America, we are guided by a common purpose to help ... We are looking for an energetic, self-motivated, and experienced Regulatory Compliance and Research Specialist to ensure we operate...the dangers and resulting consequences of illegal and illicit drug use and alcohol abuse. Our Drug -Free… more