Regulatory Professionals

Senior Regulatory CMC Manager

11 Oct 2018
14 Feb 2019
Regulatory Affairs, CMC

Senior Manager/ Associate Director, CMC
Hertfordshire, UK (optional 2 days homeworking)
Competitive salary and benefits package
Job Ref:JO-1803-404342

Regulatory Professionals are working with a research based pharmaceutical company who works across the healthcare sector, aiming to discover and develop innovative medicines worldwide. By primarily emphasising the importance of patient health and wellbeing this company pride themselves in their ethical standards across their broad range of business activities.

Whilst this role may seem Regulatory focused, we will accept applications from candidates with a scientific/lab background and a strong understanding of CMC documentation.

Main Responsibilities:
- Accountable for CMC aspects across a variety of projects, including post approval, development, submission activities and response to question from health authorities.
- Prepare and submit IMPD-Q, module 3 for MAA or license variations
- Oversee the CMC aspects for all regulatory submissions (including, but not limited to the following:
o IND or CTA
o NDA or MAA
o Amendments and variations
o Scientific advice briefing documents
- Provide insight to regulatory strategy and manage project timelines

Application Requirements:
- Degree educated in an associated discipline (i.e. Chemistry or Pharmacy)
- Scientific background
- A minimum of 4-5 years of CMC experience as well as related experience in R&D or manufacturing
- Authored module 3 documents
- Working knowledge of the application of chemistry principles to drug development
- Experience of process validation and the development of dosage forms

If you meet the outlined requirements and are interested in this position then please feel free to send your CV to or if you have any questions regarding the role then please call 01189 522 797.
If this role is not quite right for you, but you’re interested in hearing about new career opportunities, then please still get in touch as further Regulatory roles are available. Additionally, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully placed then you’ll receive £250 worth of vouchers of your choice.

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