A Product License Maintenance Manager will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations.
Product License Maintenance Group comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product.
Once a New Drug Application is approved, a host of activities are required to set up and maintain the new drug label and essential product information (known as drug listing data) to Pfizer’s website and FDA, the National Library of Medicine (Daily Med) Website and the Drug Registration and Listing System team. Compliance activities continue with coordination of information in support of New Drug Application Annual Reports and NDA Periodic Reports. In addition, in support of EEA markets, team members will be accountable for partnering with appropriate vendors in submission of A57 records to the EMA. Team responsibilities also include managing the coordination of regulatory ancillary documents (including legalization)
and drug samples to support registration and approval products in international markets.
Responsibilities:
Associate
- Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.
- Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations,
- Delivery of Product License Maintenance Portfolio in a timely and quality manner.
- Contributes to the completion of project tasks and/or milestones
- Organizes own work to meet project task deadlines
- Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management) wi