- CVS Health (Raleigh, NC)
- …every day. **Position Summary** Responsible for researching, analyzing and interpreting state regulatory requirements, developing and drafting state -specific ... Develop, draft, submit and negotiate timely approval of high-quality regulatory filings that comply with state and...regulators. - Provide timely follow-up and response. - Negotiate regulatory objections. - Obtain regulatory approvals… more
- Sumitomo Pharma (Raleigh, NC)
- … regulatory functional plan through research, review and interpretation of related product approvals , current regulatory guidance documents and recent ... in line with the global registration strategy of the product + Supports the global regulatory lead...insurances and leaves provided in line with your work state . Our robust time-off policy includes flexible paid time… more
- Sumitomo Pharma (Raleigh, NC)
- … regulatory functional plan through research, review and interpretation of related product approvals , current regulatory guidance documents and recent ... motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the...in line with the global registration strategy of the product + Competently represents GRA on project team meetings… more
- Sumitomo Pharma (Raleigh, NC)
- …the Chief Development Officer for biopharma R&D. Responsible for providing leadership regulatory strategies for earliest possible approvals for the assets under ... and New Product Planning and assessment activities specifically related to regulatory analysis and due diligence. Also support regulatory filings and joint… more
- Cardinal Health (Raleigh, NC)
- …services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals . This function applies subject matter expertise to ... **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides regulatory affairs and product...genetic status or any other status protected by federal, state or local law._ _To read and review this… more
- Cardinal Health (Raleigh, NC)
- …knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and approvals ), ... action. + Support research to maintain a pulse on product , supplier, regulatory , and market dynamics; understand...genetic status or any other status protected by federal, state or local law._ _To read and review this… more
- Highmark Health (Raleigh, NC)
- …This job supports one or more analytical aspects of the application product life cycle, including capability enablement with cross-team dependencies within a ... product scope. Uses significant judgement and discretion to collaborate...moderately complex projects (which are cross functional, with potential regulatory risk exposure, customer service & financial impacts ).… more