Regulatory Manager

pfizer.dk

Hybrid
Lead strategic regulatory activities
Obtain and maintain marketing authorizations
Support clinical trial applications
The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs

Job Summary

  • The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.
  • Deliver Regulatory Strategy and Advise Cross-Functional Teams For assigned product and market responsibilities, develop and deliver optimal regulatory strategies to support local business and R&D goals for licensed and development products.
  • At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence.

Matching Summary

The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.

Skills & Requirements

Must-have

  • Lead strategic regulatory activities
  • Obtain and maintain Marketing Authorizations
  • Support Clinical Trial Applications
  • Deliver Regulatory Strategy
  • Advise Cross-Functional Teams
  • Manage New Registration Applications
  • Manage MA Variation Applications
  • Manage MA Renewal Applications
  • Respond to NRA queries
  • Support Third Party Licenses
  • Contribute to Good Regulatory Practice

Nice-to-have

  • Patient centric company
  • Digital transformation strategy
  • Trusting, flexible workplace culture
  • Diverse and inclusive workforce
  • Disability Confident Employer
  • Senior mentor/coach for colleagues

Key Requirements

  • Expert knowledge of national legislation
  • Experience with EU MRP/ Decentralised MAAs
  • Experience with Centralized MAAs
  • Experience with EU Markets
  • Experience with Clinical Trials Support
  • Experience with Regulatory Databases
  • Experience with Supply of Unlicensed Medicines
  • Experience with Packaging and Prescribing Information
  • Experience with MA Divestments, Cancellations, Discontinuations
  • Experience with Interruptions to Supply
  • Experience with Third Party Licenses
  • Experience with Medical Devices
  • Adhere to relevant procedures and practices

Work Rights

Not specified

Tailored Resume

Cover Letter