Director Global Regulatory Affairs

vor 3 Wochen

München, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
For our EU regional headquarters (position can also be based in an EU affiliate) we are seeking highly qualified candidates to fill the position:
Director Regulatory Affairs Oncology (m/f/x)
To provide European regulatory strategy support for assigned projects, products and non-project work. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a multi-disciplinary global product team, providing expertise on regulatory matters. Represent Regulatory Affairs in external interactions (e.g. authorities, affiliates, partners, CROs) providing expertise on regulatory strategy to achieve regional and global goals.

European regulatory strategy support for assigned projects, covering product development plans, clinical trials and Marketing Authorizations Applications (MAA) as well as product life cycle management
European Regulatory Affairs representation on global project teams providing regulatory guidance and strategy and supporting EU MAA submissions
Act as regulatory contact person for authorities for assigned projects
Participate in assigned non-project tasks and process improvements
Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus
Minimum of 10 years of experience in the pharmaceutical industry and minimum of 8 years of experience in global regulatory affairs with emphasis on early stage drug development and marketing authorization applications in Europe,
experience with clinical trials, orphan drugs and paediatric clinical development
Experience of working in a global environment as well as with National Health Agencies and EMA
Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
Excellent written and oral communication skills in English, second language preferred

Excellente Benefits
Work-Life Balance

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