My client is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver disease. They have partnered with us to fill a newly created long term Sr. Regulatory Consulting Labeling & Promotion position. In this role, you would be working closely with the VP of Regulatory Affairs while managing and overseeing regulatory review of materials related to labeling, advertising and promotion of all products.
Responsibilities:
- Lead development and maintenance of global package inserts including USPI and SmPC to support regulatory submissions
- Maintain up-to-date knowledge of laws, regulations and policies enforced by the regulatory authorities as they relate to labeling, advertising and promotion of pharmaceuticals. Advise appropriate departments within the company of these requirements
- Develop and implement strategies to maintain efficient and compliant process for review of advertising/promotional materials and other labeling materials
- Review and submit advertising/promotional materials and other materials as required ensuring full regulatory compliance for all products
- Build strong relationships with internal customers; including Commercial, Legal and Clinical.
- Build strong relationships with regulatory authorities
- Ensure compliance with internal SOPs and heath authority regulations, including compilation and submission of any required documents to regulatory agencies.
Qualifications:
- Bachelor’s degree in Biology or Chemistry, advanced degree preferred
- 10 years of industry knowledge experience (pharma, biotech, CRO).
- 5 years of experience in regulatory advertising, promotions and labeling
Number of hours worked per week: 40 hours onsite
Length of Assignment: 6 month with the possibility of extension
Position Location: San Diego, CA