Senior CMC Regulatory Consultant

This is an additional headcount for a well known regulatory consulting company who have been operating for the lasty 20 years supporting pharma, biotech and medical device clients across Europe and USA with challenging regulatory issues.

This role is for a Senior CMC Regulatory Consultant who can be based remotely, across modalities, biologics preferred, this is all within Pre-Approval.

Responsibilities

• Provide advice to clients on quality aspects of drug development and regulatory requirements.
• Ensure that the content of CMC work-packages and documentation meet requirements and ensures the approval of regulatory submissions
• Preparation of quality sections for MAA and BLA/NDA as well as for IMPD and IND
• Prepare briefing packages for agency meetings.
• Management of operational and strategical aspects with CDMOs

Requirements

• Ph.D. or master’s degree in Pharmacy, Chemistry, Biophar...