For our headquarter in Munich we are seeking highly qualified candidates to fill the position of
Regulatory Affairs Associate - EU Regulatory Procedural Management (m/f/x)
The Position:
Provide support for EU Regulatory Procedural Management for assigned projects including all pre- and post-authorisation activities ensuring a smooth run of regulatory procedures as well as regulatory compliance.
Act as a representative at project teams assigned, working with EU regulatory strategy leads, with affiliates, license partners and others to support procedural delivery of the projects
Roles and Responsibilities:
- Support assigned regulatory submissions during development and life cycle management, in alignment with Regulatory Strategists, for European and other assigned non-EU authorities
- Serve as a link between Regulatory Strategists, Product Support, and other disciplines in RA (e.g. RA-CMC, Labelling, Regulatory Operations, Clinical Trial Office)
- As assigned, represent EU Regulatory Procedural Management in global regulatory and development teams and provide EU regulatory procedural guidance and operational strategy for assigned projects
- As assigned by manager, act as the regulatory contact person for authorities pertinent to procedural matters
- Support internal communications on regulatory status for the assigned assets
- Ensure consistency across projects and global alignment/synergies
- Participate in assigned non-project tasks designed to enhance the operations and processes of Regulatory Affairs
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives
Personal skills and professional experience:
- University degree in Pharmacy, Life Sciences, Natural Sciences or Medical Science, Master preferred; Master degree in Regulatory Affairs is a plus
- Minimum of 1-2 years of experience in Regulatory Affairs; experience with EMA and CAPs is a plus
- Experience of working in a global environment in interdisciplinary teams
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation
- Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner
- Solution and detail-oriented; well organised and self-motivated
- Strong working knowledge of Microsoft Office
- Excellent written and oral communication skills in English, second EU language preferred
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