Senior Regulatory Affairs Consultant CMC – Full Remote

Job title:

Senior Regulatory Affairs Consultant CMC – Full Remote

Company

NonStop Consulting

Job description

One of our clients, a renowned regulatory consulting firm with over 20 years of global experience, is looking for a regulatory affairs expert in the pharmaceutical sector to expand their team. The company stands out for its ability to offer tailor-made solutions that facilitate compliance with regulations in both Europe and the United States.Benefits:

• Remote work flexibility
• Competitive salary package that aligns with your experience and skills
• Collaborate with top global pharmaceutical companies

Key responsibilities:

• Provide expert advice on pharmaceutical development and regulatory compliance.
• Ensure CMC documentation complies with regulatory standards for effective submission.
• Draft and prepare regulatory submissions.
• Conduct a thorough analysis of clients’ documentation, identifying any strategic gaps.
• Coordinate and lead meetings with regulatory agencies and clients.
• Offer both operational and strategic support to client companies.

Requirements:

• PhD in Life Sciences (e.g., Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology).
• At least 10 years of experience in pharmaceutical regulatory affairs, with a focus on CMC.
• In-depth knowledge of ATMP or Small Molecules.
• Proven experience in regulatory filings.
• Excellent knowledge of English; German is a plus.
• Willingness to relocate to Munich.

If you are interested in this opportunity, please send your CV directly to me, Larissa Lauricella, through the NonStop Consulting website or my LinkedIn profile. Alternatively, you can email me at or call me at +49 893 704 0117 (ext. 6493). If you know someone who might be interested, we invite you to share this offer with them!

Expected salary

Location

Tirol

Job date

Sat, 28 Sep 2024 03:02:22 GMT

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