Job description
Mantell Associates are searching for a Regulatory Affairs Manager for a rapidly growing CDMO, who are doing phenomenal work with a recently by acquiring a new company on the West Coast.
Your new company is looking for a Regulatory Affairs Manager. You will be given a full product line to manage and phenomenal growth and development within the organisation. This opportunity is home based with some travel required.
You will be a joining a team of passionate professionals across the entire organisation and be part of a company that is doing exceptionally well.
Regulatory Affairs Manager – Responsibilities:
Review and approval of technical reports written in support of regulatory submissions.
Review of validation documentation including manufacturing process protocols and master batch records.
Review of technical documents and reports (such as review development reports); provide guidance/consultation for the preparation of various sections (with an emphasis on the CMC section), to insure successful regulatory filings in compliance with Regulatory agency requirements.
Regulatory Affairs Manager – Requirements:
You must have minimum a of 6+ years of experience with Regulatory Affairs
Previous experience of dealing with regulatory agencies and FDA is a must
Practical experience in small molecules
Bachelor’s Degree in Science discipline