International Regulatory Affairs Liaison Lead (m/f/x), München

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter.

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

International Regulatory Affairs Liaison Lead (m/f/x)

Purpose of the function

To provide International Regulatory Strategy support for projects, products and non-project work. Act as a single point of contact for Tier 2 and 3 country regulatory submissions, accountable overall for filing strategies and marketing application reviews in these regions. Represent International Regulatory Affairs internally working on a collaborative basis with Global Regulatory Leads to become a fully recognised member of a multi-disciplinary global project team, providing expertise on international regulatory matters.

Role and Responsibilities:

• Advise and support Local/regional regulatory teams for assessing regulatory landscape and regulations to optimise our regulatory strategies and submission plans within and across the product portfolio and provide actionable Regulatory Input into Development Strategy to enable timely commercial desirable registrations across the regions.
• Advise global teams on any specific local requirements or gaps in the global clinical development to support local submissions and collaborate to develop mitigation plans (e.g. bridging/sub-population requirements).
• Champion for countries to obtain the needed global and regional resources (e.g. to participate in global registration-directed trials, to prepare bridging reports, to respond to health authority queries rapidly).
• Interface between Global and Local Regulatory Teams and communicate project specific information to local teams, ensuring alignment between registration/submission requirements and local development plans, translate global regulatory expectations into local plans and lead the execution of these plans.
• Strategise with Global Regulatory Lead (GRL) and other core Global Regulatory Team (GRT) members on the regulatory strategy for NCEs and major variations (e.g. line extensions, new indications, label enhancements). Co-lead with Global Regulatory Leads (GRLs) development and execution of the Global Regulatory Engagement Plan.
• Participate in external partnership negotiations, execution and implementations, when applicable, to ensure advanced awareness of regulatory risks and seamless integration.
• Represent Global Regulatory Affairs on International product issues, and on specific non-product related projects.
• Participate or lead assigned non-project tasks and process improvements pertinent to International Regulatory Affairs.
• Keep current with, review and interpret international regulatory and scientific regulations and initiatives, communicate important changes and trends with the relevant stakeholders, making recommendations to senior management.

Profile

• 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
• Minimum of 8 years of experience in global regulatory affairs with emphasis on International drug development and marketing authorisation applications in LATAM, Eastern European Region, Middle East as well as other International Markets.
• Experienced people leader.
• Experience of working in global environment.
• Proven ability to plan, coordinate and lead submission activities simultaneously.
• Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation.
• Ability to develop and maintain good relationships, gain the trust of others, challenge views and 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, Spanish and/or French as a second language preferred.

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.