Aachen - Head Regulatory Affairs Mature Brands (m/f).

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Leading and managing a team of nine Regulatory Affairs Managers who have global regulatory responsibilities for Grünenthal’s Mature Brands portfolio.Key activities of the team include To submit applications for marketing authorizations, variations and renewals worldwide and to actively manage all regulatory procedures To coordinate submission of CTAs To provide input into key clinical, preclinical and CMC documents To develop fit-for-purpose  worldwide submission strategies for obtaining and maintaining marketing authorizations To obtain scientific advice from regulatory health authorities Providing strategic input and regulatory guidance during the entire life-cycle of a medicinal product Representing Global Regulatory Affairs in cross-functional management teams Having a central liaison function with subsidiaries, external partners and health authorities     Your profile:   A university degree in Life Science (pharmacy, biology, chemistry or comparable discipline), At least five to ten years of experience in Regulatory Affairs within the pharmaceutical industry, particularly with regulatory maintenance in  the European Union, Latin America and other countries worldwide A solid knowledge of relevant guidelines A good understanding of value potential and opportunities of ...

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