Regulatory Affairs Specialist

About Daiichi Sankyo Europe

We are a leading global pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide. With over 120 years of experience and more than 17,000 employees in over 20 countries, we strive to become a global pharma innovator with competitive advantage.

Our European headquarters are located in Munich, Germany, and we have affiliates in 13 European countries and Canada.

Job Title:

Director Regulatory Affairs Oncology (m/f/x)

Role Description:

The position is responsible for providing 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. The ideal candidate will act as a specialist in the area of oncology and represent Regulatory Affairs internally, working on a collaborative basis both within Europe and globally as a member of a multi-disciplinary global product team.

Key Responsibilities:

• 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

Requirements:

To be successful in this role, you should have a Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus. You should also have minimum of 10 years of experience in the pharmaceutical industry and minimum of 8 years of experience in global regulatory affairs with emphasis on late stage drug development and marketing authorization applications in Europe.

Benefits:

This position is eligible for a referral amount of €2,000. The bonus will be paid out after the referral has successfully completed the first 6 months.

Location:

Munich, Germany or other European affiliates