- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, ... Job DescriptionAssociate Director , Business System Labeling Management Required experience and...and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement… more
- Tyson Foods, Inc. (Springdale, AR)
- Job Details: Job Purpose/Summary: The Director of Regulatory Compliance is responsible for ensuring that the organization adheres to all applicable laws, ... risks and ensure regulatory adherence across the organization. The Director of Regulatory Compliance will work closely with various departments, provide… more
- Mattel (El Segundo, CA)
- …all our brands, partners, and suppliers. The Team: The Global Quality, Safety, Regulatory Compliance , Governance & Risk, Consumer Services, and Sustainability & ... programs. Job Description The Opportunity: Mattel is seeking a Director to lead our Project Management Office while serving...end-to-end change management. In addition to supporting quality and regulatory compliance , this role will help foster… more
- Kyowa Kirin North America (Princeton, NJ)
- …Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs, Advertising and Promotion Compliance will independently review, ... labeling material for an assigned product to ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for… more
- Olema Oncology (San Francisco, CA)
- …feel better, longer. For more information, visit us at www.olema.com. About the Role Director , Regulatory Labeling As the Director , Regulatory Labeling, ... end-to-end label implementation. This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA),… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at our ... location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of… more
- Duke University (Durham, NC)
- …with sound judgment. Knowledge of accrediting organization standards and regulatory compliance . Strong problem-solving, analytical, and negotiation skills. ... discover how we can advance health together. Position Summary The Assistant Director , Accreditation and Regulatory is responsible for leading system… more
- Sutro Biopharma (South San Francisco, CA)
- Description Sutro Biopharma, Inc. is looking for a Director , Regulatory Affairs Medical Writer who will provide leadership in development and execution of ... of scientific writing and will work cross-functionally, advising the team on regulatory expectations for document content while maintaining compliance with… more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- … of Post-Marketing is responsible for providing management of a post-marketing regulatory activities, ensuring compliance with regulatory requirements, and ... Supernus products. Essential Duties & Responsibilities: Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this party… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership...of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- …on frequent interactions with technical teams Review technical documentation to ensure regulatory compliance and conformance with existing regulatory ... Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant...regulatory plans. This position will report to the Director , Regulatory Affairs and collaborate with … more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align… more
- Insmed Incorporated (San Diego, CA)
- … of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene ... maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability to ensure that a strategic… more
- Merck & Co. (Rahway, NJ)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. - As an ... Associate Director , you will represent QP2 on cr o ss-...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate … more
- Eisai, Inc (Nutley, NJ)
- …research strategy across teams, to accomplish critical milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level ... profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at...opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase… more
