- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of ... throughout the organization. The Senior Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading, and… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …Building Effective Teams RELATIONSHIP WITH OTHERS: Reports to the Sr Director , Quality and Regulatory Affairs . Manages group of exempt direct reports. ... Job Title Sr Manager - Quality Testing Requisition JR000014963 Sr Manager - ...our laboratories + Ensure compliance with and oversee compendia affairs for SpecGx MINIMUM REQUIREMENTS: Education: BS in Chemistry,… more
- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety &...governance model to drive Research Profile/Target Product Profile and Quality Target Profile. + Provide consistent regulatory … more
- Bayer (NJ)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Director US Regulatory Affairs Liaison** The Director US ... US registrations. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Regulatory Affairs Liaison, are to: +… more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area ... important new medicines for devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in the Ascendis Pharma corporate… more
- Abbott (Lake Forest, IL)
- …Opportunity** Our location in **Lake Forest, IL** currently has an opportunity for the ** Director of Regulatory Affairs .** The function of a Director ... years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination… more
- ADM (Chicago, IL)
- **96226BR** **Job Title:** Senior Director of Regulatory & Scientific Affairs , Health & Wellness **Department/Function:** Research & Development **Job ... Description:** **Senior Director , Regulatory and Scientific Affairs ,...quality , marketing and product management departments in ensuring regulatory compliance of products and marketing tools. + Check… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** Are ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...consideration of patient experience data (eg, Patient Report Outcomes, quality of life measures). This strategic input ensures alignment… more
- Caldera Medical (Westlake Village, CA)
- Director of Regulatory Affairs ONSITE in Westlake Village, CA Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the ... Hiring Manager: The Director of Regulatory Affairs will...and integrate into internal processes. * Collaborate with R&D, Quality , Clinical, and Marketing teams to align regulatory… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... Your skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is… more
- Teva Pharmaceuticals (West Chester, PA)
- Director , Regulatory Affairs - Dossier Project Manager Date: Jun 20, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... Medicine Dossier Project Manager, a key member of Global Regulatory Affairs , will be responsible to develop...regulatory project plans for major global dossiers. The Director that fills this highly visible role will work… more
- IQVIA (Columbia, MD)
- MCRA an IQVIA business is seeking an Director , Cardiovascular Regulatory Affairs to be a critical team member supporting regulatory strategy and ... of overall regulatory strategy, and communicating with regulatory bodies and clients. The Director will...current agency experience is required. + 7+ years of regulatory affairs experience required. + 4+ years… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …stem cell transplant. In this position you will build and lead a cell medicine regulatory affairs team and provide regulatory leadership and oversight to the ... development of innovative regulatory affairs and CMC regulatory ...investigational and commercial products + Directs and oversees the Regulatory CMC function in preparing high- quality CMC… more
- Merck (Austin, TX)
- **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The ... updates. + Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position ... will report to the Head of Regulatory Affairs and will oversee and/or manage...review of the facility DMF and/or authoring the facility-based Quality Modules in regulatory applications (eg, IND,… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …learn, grow and become your best self. Become a **maker of possible** with us. The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs ... with RA business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in interactions/negotiations with global… more
- System One (Malvern, PA)
- Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type: Direct Hire Essential Duties/Responsibilities: + Manage Regulatory and ... sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with...get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… more
- Merck (Madison, WI)
- …Capability, People Leadership, Policy Implementation, Project Management, Project Tasks, Regulatory Affairs Compliance {+ 4 more} **Preferred Skills:** ... **Job Description** ** Director , Combination Product Regulatory CMC -...content or processes may also be required.Provide evaluations of regulatory state of affairs of any devices… more