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