Regulatory Affairs Manager CMC

Regulatory Affairs Manager CMC

Bavarian Nordic

Planegg, Germany

Would you like to join a dedicated global Regulators Affairs Team to ensure development and market access of key vaccines within infectious diseases? Do you enjoy leading regulatory projects in a very agile organization?

This is how you impact the people we are here to serve

Our vaccines make a real difference to people, and no matter your role we all contribute to protecting lives every day. This is how your work matters:

• Responsibility for the lifecycle management (LCM), including market expansions, of our smallpox/monkeypox vaccine (MVA-BN licensed as JYNNEOS, IMVANEX and IMVAMUNE in US, Europe and Canada);
• Lead the regulatory submission strategy, identify submission risks and opportunities and execute through to approval;
• Provide CMC regulatory advice to subject matter experts based on current regulatory guidance and sound scientific rationales;
• Provide regulatory assessment to proposed CMC changes;
• Lead the preparation of responses to questions from Regulatory Authorities for your area of responsibility;
• Support the preparation and conduct of Agency meetings.

Are you our next pioneer?

Succeeding with our vision of becoming one of the largest pure play vaccine companies in the world is no walk in the park, and that is why we need people like you who are determined to make it happen and have the following qualifications:

• Degree within life sciences, preferably M. Sc. in chemistry or pharmacy, Ph.D. or similar;
• Relevant experience (5-8 years) within the pharmaceutical or biotech industry, specifically within CMC regulatory affairs from a global perspective or a regulatory agency;
• Background in vaccines is preferred;
• Experience liaising with regulatory agencies;
• In-depth knowledge of current global rules, regulations and guidance governing Regulatory LCM of drugs and biologics;
• Fluent in English.

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