Director Regulatory Affairs Oncology, early stage (m/f/x)

at  Daiichi Sankyo Europe

To provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. 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.

EDUCATION & PROFESSIONAL EXPERIENCE:

• 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 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
• Excellent written and oral communication skills in English, second language preferred

• 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
• Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders