Regulatory Affairs Manager – CDMO – East Coast USA

Posted 16 September 2021
Salary 0 - 130,000
LocationUnited States of America
Job type Full Time
DisciplineCDMO & CMO
Contact NameJess Hampson

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

What to do next:
Mantell Associates are a specialist Pharmaceutical and Life Sciences Recruitment organisation. Reach out to Jess Hampson on +44 203 778 0990 or jess.hampson@mantellassociates.com.