External Consultant, Regulatory Affairs, Emea

vor 1 Tag

Zug, Schweiz Reata Contractors Vollzeit

The External Consultant, Regulatory Affairs EMEA, will lead all the relevant regulatory activities related to an assigned nephrology program including coordination of MAA activities across the EMEA region. This role will ensures the timely and high quality execution of the EMEA regulatory strategy for the assigned program.

**RESPONSIBILITIES**:

- Participate in the development of regulatory strategies and tactical plans for the assigned product in collaboration with cross-functional teams
- Work closely with the Head of RA EMEA and departments area Operations, Submission Management, CMC, and Commercial Support)
- Be an active member of the global regulatory subteam providing regional input to global regulatory strategies
Ensures compliance with EMEA regulatory requirements for assigned projects
**CORPORATE COMMITMENTS**:

- Demonstrate commitment and support for company goals, objectives and procedures
- Demonstrate professionalism and adherence to moral, ethical and quality principles
- Comply with applicable regulations, GCP, GMP, and corporate policies and procedures
**CANDIDATE REQUIREMENTS**:

- Experienced professional with a minimum of 8 years of relevant experience and a proven track record of EU (EMA and EU country-specific competent health authority) regulatory submissions
- Recent hands-on experience with the planning and submission of CTAs and MAAs in electronic format
- Experience leading or participating in regulatory agency interactions
- Must have solid foundation in science obtained through academics and business experience
- Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills
- Strong knowledge of EU Directives and guidance documents pertaining to pharmaceutical drug development, including knowledge of evolving global requirements for electronic filing of regulatory submissions

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