- Merck & Co. (San Diego, CA)
- Job DescriptionThe Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the ... indications, formulations, or external partners. The Liaison engages directly with global regulatory authorities to ensure successful registration and… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs ... VP of Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Nura Bio (South San Francisco, CA)
- …experience in both large and small pharmaceutical organizations. *In-depth knowledge of global regulatory requirements and guidelines. *Proven track record of ... central, peripheral, and ocular nervous system. The VP/Head of Regulatory Affairs will be a key member of our...regulatory agencies, including the FDA, EMA, and other global health authorities, to facilitate the approval process. *Lead… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible ... regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance,… more
- Merck & Co. (Rahway, NJ)
- … regulatory requirements such as ISO, USP, FDA guidelines, and other global regulatory standards pertaining to medical devices and combination products.Proven ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
- Merck & Co. (Rahway, NJ)
- …multiple large molecule programs across a variety of platformsExpert knowledge in global regulatory requirements for large molecule commercialization and BLA ... are developed by working teams supporting the product.Compile with our company's Global and regulatory requirements and execute current Good manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project portfolio and prioritize and drive projects from inception through regulatory approval to global implementation.Requirements BS required, Ph.D. preferred ... manufacturing network and drive change management process from inception through regulatory approval to global site implementation.Candidate must have extensive… more
- Protagonist Therapeutics (Newark, CA)
- …raw materials, regulatory starting materials, and drug substances that meet global regulatory expectations. Work with multiple CDMOs in sourcing amino acids, ... of peptide and organic process R&D literature. Maintain a current understanding of global regulatory health care requirements, ICH and FDA guidelines, and filing… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of technical… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of technical… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. As an individual contributor, the associate director… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical affairs, or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (South San Francisco, CA)
- …execution, reporting and interpretation of data. Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategiesIn-depth knowledge of global regulatory requirements for distribution including good distribution ... along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team.The Associate Director will lead a team of technical… more
- Merck & Co. (Rahway, NJ)
- …risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for distribution including good distribution ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of technical… more
- Merck & Co. (Boston, MA)
- …experience in drafting regulatory documents and interactions with global regulatory agencies requiredSelf-driven leader willing to advance Precision ... Research, Mentorship, Parasitology, Patient Care, Professional Networking, Protocol Development, Regulatory Compliance {+ 4 more}-Preferred Skills:Job Posting End Date:10/2/2025… more
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