- ThermoFisher Scientific (Greenville, NC)
- …Document Specialist (GL&LDS) Team is responsible for managing global labeling activities and ensuring compliance with international regulatory standards. ... strong organizational, technical, and regulatory expertise to manage complex global labeling operations within a matrixed environment. + Acts as a … more
- Sumitomo Pharma (Raleigh, NC)
- …for the position of Associate Director Regulatory Affairs. The Associate Director is part of the Global Regulatory Affairs (GRA) team based ... the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory...support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL as… more
- Sumitomo Pharma (Raleigh, NC)
- … Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- GRAIL (Durham, NC)
- … plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing ... North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information,… more
- ThermoFisher Scientific (Greenville, NC)
- …Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day ... our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping… more
- United Therapeutics (Research Triangle Park, NC)
- …to "roll up your sleeves" and be hands-on whenever needed. The Senior Director of Quality Operations for Solid Dose leads site quality operations, including all ... Ensure that the facility operations are in compliance with regulatory procedures and guidelines; accountable for the review and...in the review and approvals of product packaging and labeling + Host Health Authority inspections and ensure overall… more
- ThermoFisher Scientific (Wilmington, NC)
- …illness and evaluate patient outcomes, preference and/or adherence, while supporting promotional and labeling claims on a global scale. This is a fully remote, ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...to staff for project work and relevant methods and regulatory issues + Maintain high external visibility as recognized… more
- Chiesi (Cary, NC)
- …consisting of cross-functional medical colleagues including provides medical input on US labeling and regulatory interactions + Ensures timely and appropriate ... is to lead the PAH/PH-ILD US Medical Affairs team, ensuring alignment with Global Medical Affairs to execute the medical operating plan and Medical Affairs strategy… more
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