- 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
- Novo Nordisk (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions + Serve ... in drug development required + Demonstrated knowledge of global regulatory requirements for drugs and biologics + Proven ability to develop robust regulatory … 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
- Merck (Millsboro, DE)
- **Job Description** ** Associate Director , Animal Services** **About the Job** Animal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the ... role of Associate Director . This position will have overall...other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual ... submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide guidance to PST teams by… more
- Organon & Co. (Plymouth Meeting, PA)
- … in Organon Regulatory Chemistry, Manufacturing and Controls New Products, the Associate Principal Scientist ( Associate Director ) is responsible for ... development, analytical, and quality assurance) is preferred. + Direct experience in Regulatory CMC Biologics and/or authoring of regulatory documentation.… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Analytical Quality Assurance Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company ... combination products. This role will report to the Sr. Director of GMP Quality Assurance. The ideal candidate will...at CMOs/CLOs. * Ensure CMOs and CLOs comply with regulatory standards, company requirements, and Quality Agreements. * Provide… more
- J&J Family of Companies (Spring House, PA)
- Johnson & Johnson is recruiting for an Associate Director , Cell Therapy Process Development based in Spring House, PA. At Johnson & Johnson, we believe health is ... we all belong. We are looking for an energetic and highly motivated Associate Director candidate with demonstrated expertise in autologous cell therapy process… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and local country ... and cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communication + Ensures consistent and unified safety… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Advanced Degree in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+ years experience with demonstrated ... covering all therapeutic modalities, including small molecules, traditional and complex biologics and next gen cell therapies. All therapeutic areas are supported.… more
- Merck (Rahway, NJ)
- … regulatory agency regulations and requirements + Experience in Biologics and/or Vaccine method development, characterization, technology transfer, and release + ... a variety of Quality or compliance-related issues + Interprets complex regulatory requirements for various audiences, including source area management, and… more
- University of Maryland, Baltimore (Baltimore, MD)
- …visits. This program covers all major areas of drug product and biologics regulatory science, including: Chemistry, Manufacturing, and Controls (CMC); Clinical ... and Drug and Biologics Discovery. Additionally, responsibilities include a Certificate in regulatory science, which is the first two courses in the MS in … more