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

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For our European headquarters (position can also be based in an EU affiliate, excluding Belgium and Greece) we are seeking highly qualified candidates to fill the position:

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

The Position:

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.

• 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

• 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

• Excellent Benefits
• Work-Life Balance
• Growth and Development
• Health and Wellbeing Support