- Takeda Pharmaceuticals (Boston, MA)
- …of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant ... based on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... Leads the Chemistry, Manufacturing, and Controls ( CMC ) & Combination Products (CP) Internal Medicine team....be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… more
- Boehringer Ingelheim (Athens, GA)
- …with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from ... expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development… more
- Regeneron Pharmaceuticals (Troy, NY)
- …manufacturing group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate ... conjugates, peptides). Responsible for end-to-end operational coordination-linking Manufacturing, R&D, CMC , clinical, regulatory -to enable accelerated development and… more
- Regeneron Pharmaceuticals (Troy, NY)
- …manufacturing group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate ... We are hiring an Executive Director to lead operations and program management for...execution from early development through commercialization, ensuring timely supply, regulatory readiness, and strategic coordination across all technical and… more
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted:… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a key ... application should be directed to Chat with Ripley. R1596806 : Senior Director , Global Regulatory Lead Neuroscience **Company:** Bristol-Myers Squibb **Req… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Strategy Requisition ID: 7214 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the challenges are ... - Open to candidates within the United States** The Director , US Regulatory Affairs Strategy, oversees the...regulatory affairs cross-functional team on a dotted-line basis ( CMC , Regulatory Operations, US Labeling, Promotion Compliance… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, ... Opportunity - open to candidates in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead and oversee… more
- ThermoFisher Scientific (Wilmington, NC)
- …Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** Join Us as a Director Regulatory Affairs - Make an Impact at the Forefront ... of Innovation The Director Regulatory Affairs provides operational leadership for...guidelines; advanced knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC , publishing,… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Bristol Myers Squibb (Seattle, WA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and… more
- Bristol Myers Squibb (Madison, NJ)
- … CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments. + Provides technical quality expertise and compliance oversight ... . **Position Summary** Bristol-Myers Squibb is seeking an Associate Director , Principal Product Quality Leader (PQL), in Global Product Quality… more
- BeOne Medicines (Pennington, NJ)
- **General Description:** The Associate Director Quality Control (QC) will lead analytical strategy, method lifecycle management, and QC operations to support GMP ... international regulations. The position requires strong cross-functional collaboration with Regulatory Affairs, Process Development, Manufacturing, and Quality teams, as… more
- Catalent Pharma Solutions (Kansas City, MO)
- …staffing, and maintaining the Quality Management Systems (QMS) to assure the site /division is compliant with regulatory , Corporate, and customer requirements. ... review, and building a Patient First culture at the site . The Director of Quality at the...site /division for inspection readiness; + Serve as the site 's primary contact (with both customers and regulatory… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing applications for ... best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for small-molecule… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- …interact with regulatory agencies and direct experience with site regulatory inspections.KnowledgeStrong knowledge of biologics manufacturing technologies & ... manufacturing including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership team and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Pharmaceutical Sciences counterparts. + Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision and strategy for ... Description** **Title: Process Engineer Small Molecules API Process Science (Associate Director )** **Location: Cambridge, MA (Hybrid)** **About the role:** As a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …including Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC , and the Gilead Site Quality ... Join Gilead and help create possible, together. **Job Description** **Senior Director , Global Supplier Quality** Gilead Sciences, Inc. is a research-based… more
- Amgen (Thousand Oaks, CA)
- …and/or oligonucleotide development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Amgen Quality ... us and transform the lives of patients while transforming your career. **Product Quality Director - Synthetics** **What you will do** Let's do this. Let's change the… more