Senior Regulatory CMC Consultant - Emerging Markets

Proclinical is currently recruiting a Senior Regulatory CMC Consultant with a speciality in Emerging Markets. This is an opportunity to execute regulatory strategies for new marketing authorisation applications and throughout whole product lifecycle for the European and extended European region.

Job Responsibilities

• Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
• Manages Strategy and Execution for all regulatory submissions (e.g. clinical trial, variations, extensions and marketing applications) for products within the portfolio
• Leads development of regional regulatory documents (briefing books) and meetings in accordance with global regulatory strategy
• Authoring and coordinating responses to questions across assigned products and countries.
• Provides regulatory direction on regional regulatory mechanisms to optimize product development
• CMC RA subject matter expertise for a group of countries within the EU region
• Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
  

Skills and Requirements

• Regulatory knowledge in regional legislation
• Working with policies, procedures and SOPs
• Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
• Understanding of drug development Scientific / Technical Excellence
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
• Cultural awareness and sensitivity to achieve results across both regional country and International borders.
  

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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