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 submissionsPreparation of quality sections for MAA and BLA/NDA as well as for IMPD and INDSupport due diligence.Prepare briefing packages for agency meetings.Management of operational and strategical aspects with CDMOsRequirements:Ph.D. or master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology similarAt least 6-8 years in a scientific/technical CMC development or CMC – regulatory affairs functionExperience with regulatory filings (IND/IMPD, BLA/NDA/MAA).Experience with CMC and regulatory requirements for all development stages.