Regulatory Manager

Data Science Jobs

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.
  • We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.

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
  • develop and enact influencing strategies
  • support clinical development activities
  • obtain NRA Approvals for Supply of Unlicensed Medicines
  • safeguard Compliance in Management of Packaging
  • support MA Divestments
  • support Third Party Licenses
  • adhere to relevant procedures and practices
  • contribute to Regulatory Group Development

Nice-to-have

  • patient centric company
  • breakthrough culture
  • digital transformation strategy
  • trusting, flexible workplace culture
  • diverse and inclusive workforce
  • DisAbility Confident Employer
  • unleashing the power of our people

Key Requirements

  • Expert knowledge of national legislation, guidelines and regulatory environment
  • Experience with EU MRP/ Decentralised MAAs
  • Experience with Centralized MAAs
  • Experience supporting MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity
  • Experience supporting Third Party Licenses
  • Experience supporting medical devices
  • Experience with GRP (Good Regulatory Practice)

Work Rights

Not specified

Tailored Resume

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