- Eisai, Inc (Raleigh, NC)
- …only if they meet all company policies, procedures, and regulatory requirements. This includes reviewing batch documentation and investigating deviations.Process ... System Oversight Implementation.Audit and Compliance: Maintain audit readiness, support regulatory inspections, manage complaints effectively, oversee change control, review… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr... Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... experience in drug development required Demonstrated knowledge of global regulatory requirements for drugs and biologics Proven...of global regulatory requirements for drugs and biologics Proven ability to develop robust regulatory … more
- Merck & Co. (Rahway, NJ)
- …as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the ... in bioperformance of formulationsThe Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed of… more
- Tris Pharma (Monmouth Junction, NJ)
- …Administration (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , ... Associate Director / Director , Analytical Research...She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and… more
- Merck & Co. (Millsboro, DE)
- …Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate Director .This position will have overall responsibility for oversight and ... DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development ... as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and local country ... cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communicationEnsures consistent and unified safety message… more
- Merck & Co. (Durham, NC)
- …product Technical Operations teams.Position Responsibilities:Reporting to the Technical Operations Associate Director the incumbent will independently manage ... of sterile products, making accessible our company's next generation of Vaccines and Biologics . To this end, we strive to create an environment of mutual respect,… more
- AbbVie (Worcester, MA)
- …for CMC leadership and project management for existing and new biologics projects from the drug substance perspective. Responsibilities: *Develop comprehensive ... project plans, budgets, timelines and strategy; biologics projects at all stages of development are included,...process development and process characterization to management and to regulatory agencies. *Prepare and review regulatory briefings… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …infrastructure across the site, representing EOHSS and business needs. + Supports Associate Director and Senior Leadership initiatives and activities. + Teams ... We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier...to successful business continuity. This role is responsible for regulatory compliance as well as corporate EHS requirements. This… more
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
- Boehringer Ingelheim (Ridgefield, CT)
- …lives? Boehringer Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for Chemical products ... to the continuous improvement of processes and standards within Regulatory Affairs. If you have a strong background in...Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director … more
- Boehringer Ingelheim (Ridgefield, CT)
- …For assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US ... strategic regulatory guidance to facilitate efficient and compliant drug development...Five (5) years of experience in regulated pharmaceutical industry ( biologics or small-molecule). + Requires a robust and broad… more
- BeiGene (Emeryville, CA)
- …Description:** The incumbent will: + Lead the activities of the Global Regulatory Affairs SOP Committee regarding life-cycle management of Global Regulatory ... personnel through the Document Change Process + Guide external personnel to Global Regulatory Affairs to comply with SOP Review Committee requirements + Schedule and… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies, selecting candidates for preclinical and clinical development. Join Takeda as an Associate Director where you will be the subject-matter expertise in ... + Knowledge of regulatory requirements and guidelines for drug discovery in biologics . **More about us:** At Takeda, we are transforming patient care through the… more
- Merck (Rahway, NJ)
- …as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the ... in bioperformance of formulations The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed of… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director , Upstream MSAT **Location:** Framingham, MA **About the Job** We are an innovative global healthcare company with one purpose: ... you thought was possible. Ready to get started? The Associate Director position is part of the...is one of the top performance enablers for Sanofi's biologics manufacturing network and integral to LCM. We deliver… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …is true to the best of my knowledge. **Job Description** Job Title: Associate Director , Facilities & Critical Systems Location: Thousand Oaks, CA **About ... the role:** As an Associate Director , Facilities & Critical Systems, you...uninterrupted delivery of utilities to our 24/7 commercial GMP biologics manufacturing operations. You will lead a team of… more
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