Manager, Global Regulatory Affairs Labeling & Promotion job in Cranbury
|Employer:|| Amicus Therapeutics|
|State:||New Jersey (NJ)|
Manager Global Regulatory Affairs, Labeling and Promotion SUMMARY OF POSITION
The Manager Global Regulatory Affairs, Labeling and Promotion will be responsible for supporting the development and maintenance of the Company Core Datasheets (CCDS), regional labeling for assigned product(s) and ensure compliance of labeling databases across applicable regions. Further this role will support the development and maintenance of regional labeling to ensure it aligns with the CCDS and meets the requirements of health authorities. The individual in this position will also support the provision of labeling documents intended for submissions (ie., labeling supplements, new label development) with internal and external alliance partners as required.
The Manager Global Regulatory Affairs, Labeling and Promotion must have Regulatory Affairs experience in pre and post market labeling, experience supporting the building of labeling processes, possess project management, document management, and publishing skills, including use of the Microsoft Office Suite, Adobe Acrobat and a recognized Project Management application. A B.S. or M.S. degree is required (advance degree preferred) with at least 3 to 7 years of experience required.
ROLES AND RESPONSIBILITIES
The Manager, Global Regulatory Affairs, Labeling and Promotion will:
- Leads efforts to create, modify, and review labeling documents, including core data sheet, prescribing information, patient labeling, and packaging/artwork content for use with attention to competitive positioning
- Evaluates requests for changes to labeling and those that deviate from the company core data sheet
- Supports the tracking of labeling changes and provides operational support to fulfill and meet local health authority requests and deadlines
- Coordinates response to labeling-related questions from authorities and convenes labeling working group meetings to reach content consensus with technical experts when necessary
- Partner with cross-functional teams to ensure submission-ready labeling components comply with regulatory requirements and assist with preparation of submissions to health authorities, as needed
- Track data sources supporting labeling claims, history of labeling negotiations and changes, and reasons for differences in local labeling
- Responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in labeling activities and communications
- Works collaboratively with cross-functional colleagues during labeling development and reviews.
- Provides upon request analysis of competitor labeling in the relevant therapeutic area
- Responsible for continuous quality and compliance throughout the packaging labeling process
- Member on project teams and regulatory sub-teams, as appropriate
- Contributes to the development and implementation of Corporate and Department policies and procedures related to the development of labeling.
- Reports to the Director of Global Regulatory Affairs, Labeling and Promotion
- Bioinformatics Scientist / Computational Biologist / Data Scientist Novartis Pharmaceuticals Cambridge
- AS&T Principle Analyst (ASPEX) Novartis Pharmaceuticals Fort Worth
- Computational Biologist / Bioinformatics Data Scientist Novartis Pharmaceuticals Cambridge