- Merck & Co. (Upper Gwynedd, PA)
- …Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for assigned… more
- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory /business… more
- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll Be Doing Initiate,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …office three days per week on average. Position Summary The Director of Regulatory Affairs (RA) Labeling will lead the development of a cross-functional labeling ... global labeling process Ensure labeling strategy is aligned with overall regulatory and program strategy by working collaboratively with key internal stakeholders,… more
- Smith & Nephew (Pittsburgh, PA)
- Principal Regulatory Specialist, Robotics (Pittsburgh, PA) Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living! In ... this role, you will lead and support global regulatory submissions for new and modified medical devices, including...the US and EU markets. You act as the Regulatory Affairs (RA) lead and subject matter expert (SME)… more
- U-Haul (Phoenix, AZ)
- …2721 N Central Ave, Phoenix, Arizona 85036 United States of America he Regulatory Compliance Analyst supports the Compliance, Actuarial, and Finance teams in the ... administration of Med Supp rate filings, regulatory tracking, and policyholder communications . This position assists in ensuring compliance with Medicare Supplement… more
- Actalent (Irvine, CA)
- Regulatory Affairs Specialist II Job Description The Regulatory Affairs Specialist II plays a pivotal role in ensuring that the company's medical devices comply ... with regulatory requirements throughout their lifecycle. This mid-level position involves...This mid-level position involves a blend of strategic planning, regulatory submissions, and cross-functional collaboration to support product development… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Kite and help create more tomorrows. Job Description The Senior Director, Regulatory Affairs, Advertising and Promotion is responsible for developing and executing a ... regulatory strategy that enables the global business to meet...CA, and will report to an Executive Director in Regulatory Affairs. Responsibilities: Lead, develop, and mentor a team… more
- Katalyst HealthCares and Life Sciences (Lake Forest, IL)
- Responsibilities: Regulatory Labeling Documentation. Support the creation and maintenance of assigned labeling projects to enable worldwide regulatory ... Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labeling projects in close collaboration with GLM/GL-TAL.… more
- Abbott (Minneapolis, MN)
- …colleagues serve people in more than 160 countries. JOB DESCRIPTION: International Regulatory Affairs Specialist I About Abbott Abbott is a global healthcare leader, ... health and get on with their lives. We are currently hiring an International Regulatory Affairs Specialist I to work on-site at our Plymouth, MN location. This new… more
- Katalyst HealthCares and Life Sciences (Matthews, NC)
- Responsibilities: The Senior Manager, Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, compiling and ... management of CMC sections for global regulatory filings. This role requires a strong understanding of the drug development process, pharmaceutical technology, and … more
- BNP Paribas (Jersey City, NJ)
- Business Overview: The Federal Reserve tailors its regulatory requirements for and supervision of foreign banking organizations (FBOs) to account for the size, ... an assessment of other US offices. The CUSO/IHC Local Regulatory Reporting Department is seeking an Assistant Vice President...to assist in the implementation of the required structure regulatory reports submitted to the Federal Reserve Bank, and… more
- Radiant (El Segundo, CA)
- …power for life-saving applications in hospitals or disaster-relief scenarios. Engineer - Regulatory Radiant is seeking a driven Regulatory Systems Engineer who ... support the license application approval process with the Nuclear Regulatory Commission. This role is critical to bringing the...be a go to subject matter expert for the regulatory process and collaborate across technical teams to inform… more
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