Director of Global Regulatory Affairs
Vor 6 Tagen
About the Role:
We are seeking a highly qualified Director of Global Regulatory Affairs to join our team at Daiichi Sankyo Europe GmbH. As a key member of our global product team, you will be responsible for providing European regulatory strategy support for assigned projects, products, and non-project work.
Key Responsibilities:
- Provide 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.
- Represent Regulatory Affairs internally and externally, providing expertise on regulatory matters to achieve regional and global goals.
- Act as regulatory contact person for authorities for assigned projects.
- Participate in assigned non-project tasks and process improvements.
Requirements:
- 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.
What We Offer:
- Excellente Benefits
- Work-Life Balance
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