Director Regulatory Affairs Oncology (m/f/x)

Gesellschaft: Daiichi Sankyo Europe GmbH

For our headquarter in Munich we are seeking highly qualified candidates to fill the position of

Director Regulatory Affairs Oncology (m/f/x)

The Position:

To serve as the European or global regulatory strategy lead 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 to become a fully recognised member of a multi-disciplinary 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.

Roles and Responsibilities:

• European regulatory strategy leadership for assigned projects, covering product development plans, clinical trials and Marketing Authorizations Applications (MAA) as well as product life cycle management
• European or Global RA representation on global development teams providing regulatory guidance and strategy and leading EU MAA submissions
• Act as regulatory contact person for authorities
• Participate or lead 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
• Provide regulatory expertise in participating or coordinating assigned due diligence opportunities and making recommendations to senior management

Personal skills and 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 late stage drug development and marketing authorization applications in Europe, experience with clinical trials, orphan drugs and pediatric clinical development
• Experience of working in 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

What we offer: 

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.

Please apply online at our Career Portal. We are looking foward to hearing from you.