Senior/Principal Regulatory CMC consultant (remote in EU)

Company

Regulatory Consultancy

About

Scienta are proud to be supporting an impressive, full service regulatory consultancy in Munich with a focus on drug development in Europe and the US.

Role

The role requires at least 15 years of Regulatory CMC experience, or technical CMC development experience in either Small Molecule or Biologic, or cell/gene therapy products.

The role is a mix of CMC writing, regulatory strategy, Health Authority interaction, and client consultation. Experience in pre-approval CMC activities and authoring IMPDs is required.

This role can be worked remotely within Europe.

Experience

• D. or master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable
• At least 15 years in a scientific/technical CMC development or CMC – regulatory affairs function
• Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
• Excellent communication and negotiation skills in English. German language skills are a plus
• Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial
• Highly motivated team player with strong interpersonal abilities
• Sound knowledge of Microsoft Office applications
• Willingness to travel moderately (Meetings with clients, agencies or CMOs)​

Why Apply?

This is an opportunity to join an impressive consultancy with a fantastic reputation, cutting-edge projects, and a very generous compensation package including paid overtime.