Senior Regulatory Affairs CMC Consultant – Great Opportunity

Job title:

Senior Regulatory Affairs CMC Consultant – Great Opportunity

Company

NonStop Consulting

Job description

Our client is a well-known global regulatory consulting firm with over 15 years of experience and a stable work environment. With plans to grow the team from 45 to 80 members in the next two years, this is an exciting opportunity to join a successful and expanding company. Specializing in expert advice on clinical trials in Europe and the US, our client offers engaging and impactful work.

Benefits:

• Relocation assistance to Munich (incl. Visa support)
• Prime location in the heart of Munich, providing excellent access to public transportation, accommodation, and a vibrant city atmosphere
• Competitive compensation and a friendly, collaborative work culture with opportunities for autonomy

Responsibilities:

• Provide guidance to clients on quality aspects of drug development and regulatory requirements to facilitate strategic and operational decision-making
• Ensure that CMC work-packages and documentation align with regulatory expectations and support the approval of submissions
• Develop quality sections for regulatory submissions and participate in agency meetings with clients, contributing to successful outcomes

Requirements:

• PhD or master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a related field
• Minimum of 5 years of experience in scientific/technical CMC development or CMC-regulatory affairs
• Excellent communication skills in English, with proficiency in German as a plus

If you are interested in this position, please apply here or send your resume to me, Elisa Cresci, on the NonStop Consulting website or through my LinkedIn profile.

If you are not available but know someone who might be interested, please forward this message to them and support the people in your network.

DE: +49 893 704 0117

Internal Extension: 6476

Expected salary

Location

Österreich

Job date

Sun, 17 Mar 2024 00:45:21 GMT

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