\\n With our corporate philosophy of \\xe2\\x80\\x9ccaring for life\\xe2\\x80\\x9d, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.

Your assignments

Main Tasks:

• Own the regional RA strategy for non-EU, non-US countries
• Represent regulatory and contributes to the Product Team
• Represent the Regulatory Affairs Group at cross functional or intercompany committees
• Lead management of submission roll out strategy for initial and life cycle management filings
• As Business partner to the Fresenius Kabi Regions (LATAM, APAC, MCST China and BU Biosimilar Commercial and supply chain team, develop, and lead the regional regulatory strategies and activities in alignment with other RA functions
• Ensure compliance of regional regulatory roll out processes
• Act as RA lead for development projects, member of the RA subteam

Other tasks:

• Educate local FK affiliates and Regulatory Agencies on Biosimilars and BU Biosimilars strategies and processes
• Provide Regional Regulatory Affairs expertise on Biosimilars for assigned development projects
• Manage the completion of the relevant documentation to allow timely submissions for the assigned products/countries
• Manage, plan and timely finalize responses to questions from Authorities
• Prepare or oversees preparation of briefing books and lead and provide support at Regulatory agencies meetings
• Ensure that Change Control Proposal (CCP) consider the implications for respective regions

• Represent Regional Regulatory Affairs on the regulatory subteam for the assigned projects

• Serve as an interface between company functions as appropriate
• Carry out any other tasks as required by the function to achieve its mission and objectives

Your profile

Education

• Degree in a Life Science or related discipline and possible higher degree

Work experience

• At least 10-12 years pharmaceutical experience of which at least 6-8 years in regional regulatory, ideally including Biologics
• Experience in managing submission roll out for initial marketing authorization applications and life cycle management submissions
• Experience in interaction with regulatory agency in agency meetings for non-EU/-US regions (e.g. ANVISA, TGA, Health Canada, NMDA etc)
• Experience in biosimilars

Job-specific competencies & skills

• Excellent spoken and written English. A second major language would be an advantage
• Excellent written and spoken communication skills
• Excellent interpersonal skills
• Understanding of Regulatory Affairs contribution to Pharma business
• Good organizational and planning skills
• Ability to think strategically
• Ability to manage multiple tasks in parallel
• Ability to lead and work in teams

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