- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant experience in small molecules is ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport...MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the… more
- AbbVie (North Chicago, IL)
- …. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on ... Senior RA Specialist will also support related regulatory affairs activities, such as development, execution...requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category… more
- Parexel (Nashville, TN)
- … regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary ... to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and...in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation… more
- Sumitomo Pharma (Lincoln, NE)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the US....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Vice President of Regulatory Affairs will serve as the senior -most regulatory leader responsible for envisioning, developing, and ... post-marketing activities. Team Leadership * Lead, mentor, and retain a high-performing Regulatory Affairs team, including Regulatory Operations, Labeling,… more
- ThermoFisher Scientific (Greenville, NC)
- …company, all while maintaining full-time benefits. **Position Summary** The Director, Clinical Regulatory Affairs serves as a senior regulatory ... RFIs to support timely trial startup and advancement. The Director, Clinical Regulatory Affairs partners closely with Clinical Operations, Clinical Development,… more
Related Job Searches:
Affairs,
Affairs Senior,
CMC,
CMC Regulatory,
Regulatory,
Regulatory Affairs,
Regulatory Affairs CMC,
Senior,
Senior Regulatory Affairs