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Hyper Recruitment Solutions
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Senior Regulatory CMC Manager

Experience Dependant
Job Reference: J5630785
Updated On: 18/06/2019
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Biotechnology, Cell & Gene Therapy

Skills: Regulatory Affairs - CMC, Regulatory Affairs - ATMPs

Job Information

Role Overview

A fantastic opportunity for a CMC Regulatory Manager has opened within a rapidly growing Cell and Gene Therapy company based in the Hertfordshire area. As the CMC Regulatory Manager you will write all Regulatory CMC documentation including Module 3 for CTA, IMPD, IND and MAA submissions. You will also assist with the development of the company's CMC regulatory strategy to ensure the successful development of life changing ATMP medicinal products.

Key Duties and Responsibilities

Your duties as the Senior CMC Regulatory Manager will be varied however the key duties and responsibilities are as follows:

1. You will develop the CMC regulatory Strategy and use your extensive CMC experience to identify potential Regulatory challenges.

2. You will lead the preparation of CMC regulatory documentation ensuring timelines are maintained. You will work as part of a matrix team and gain insight for the scientific staff.

3. You will offer CMC regulatory guidance to the scientific staff and key stakeholders within the company and co-ordinate CMC focused meetings with regulatory agencies.

4. You will write CMC Regulatory documentation including but not limited to CMC question responses, CMC Scientific Advice briefing packages, Modules 2 and 3, PIP / PSP and PRIME.

Role Requirements

To be successful in your application to this exciting opportunity as the Senior CMC Regulatory Manager we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline (e.g. Biology, Biotechnology, Pharmacy, Pharmacology etc.) in addition to extensive CMC understanding and knowledge.

2. Proven industry experience in a CMC Regulatory setting, ideally within a Biotechnology, Biologics or Biopharmaceutical industry. This includes leading and advising on CMC regulatory strategy as well as hands on experience with CMC documentation writing.

3. A working knowledge and practical experience with Advanced Therapies would be a benefit to your application. Rare disease experience or novel therapeutic platform development is desirable.

Key Words: CMC | Regulatory Affairs | CMC Manager | Module 3 | Biologics | ATMP | Rare Disease | Gene Therapy | AAV vectors | CMC Documentation
Georgia Walden
Your Recruitment ConsultantGeorgia WaldenGeorgia.walden@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.