Regulatory Affairs CMC Manager - Biologics

2019-02-27 20:00:082019-12-17LinkField Life Sciences
Job TypePermanent
AreaNorth London, UK
SectorPharma / Biotech
Salary£ 60,000 ~ 70,000 Annual Rate
Job Ref0064I00000rzyBGQAY
Job Views1104

I am currently partnering with a ground breaking clinical stage biotechnology company who are looking to expand their talented team by hiring a Regulatory CMC Manager to work alongside their CMC Director. With a growing clinical portfolio, early phase Regulatory CMC experience is needed for this position. Ideally the successful candidate will have a biotech or biologics background and experience working with rare disease products, although this is notessential. 

This is an excellent opportunity to join an outstanding organisation going through a period of growth and development and plays a pivotal role in developing life changing medicines. 


·      To work closely with other regulatory sub-teams to develop CMC regulatory strategy, prepare CMC regulatory documents, contribute in regulatory meetings and ensure ongoing compliance.

·      Provide regulatory input to help shape CMC regulatory strategy, identifying potential regulatory challenges and tools for optimising the time/cost/risk profile.

·      Preparation of CMC regulatory documents including managing writing/reviewing timelines and compiling finished documents

·      To work on responses to CMC regulatory questions, CMC scientific advice briefing documents, CMC Module 2 and 3 documents, PIP/PSP, PRIME, Breakthrough/RMAT, etc.

·      To co-ordinate company preparations for CMC meetings with regulatory agencies

Experience Required: 

·      Strong scientific background 

·      Educated to at least degree level preferably in a biological science or pharmacy

·      Technical and/or regulatory experience of biologics

·      Experience of regulatory strategies for rare disease and/or novel platform development is desirable

This position may require a small amount of travel to meetings in Europe, US or further afield as the role requires.

For further information on this position please get in contract with Natalie Jones on 0207 183 5059 or email Natalie directly at

Apply Later
Sign in
Register with
Natalie Hopkins
Recruitment Director
Browse Natalie's jobs
View Natalie's bio
Get in touch with Natalie
0207 183 5059
Similar Jobs
  • Regulatory Affairs Manager / Consultant (Permanent)
    UK, London, North London
    Pharma / Biotech
    £ 45,000 ~ 60,000 Competitive

    We are currently working with a growing Regulatory group working with a wide variety of products globally. We are seeking a regulatory professional with strong Regulatory Divestment and Post Licencing experience to join a friendly, thriving team.


    Location: Hertfordshire office or h...

  • Regulatory Affairs Senior Executive - Clinical Trial Application
    UK, London, North London
    Pharma / Biotech
    £ 40,000 ~ 47,000 Annual Rate

    We are currently working with a growing Regulatory group working on a wide variety of products and therapy areas. They are currently seeking a professional with strong Regulatory Clinical Trial Application (CTA) experience to join their thriving team.

    Location: Hertfordshire offi...

  • Regulatory Affairs Manager UK & Ireland - part time (3 days per
    UK, London, Central London
    Pharma / Biotech
    £ 50 ~ 70 Hourly Rate

    We are currently working with a Specialist Pharma company with a global presence.


    This is a role involves heading up Regulatory Affairs activities for the UK / Ireland Affiliate for 3 days a week. The role acts as a local safety representative for Pharmacovigilance p...

Email Me Jobs Like This
Subscribed to similar jobs notifications

To find out more about Linkfield Life Sciences Ltd, and how we can partner with you to support your Regulatory Affairs recruitment requirements, please contact us below:


Office 2b
Mercury House,
High Street,
Tattenhall, TN8 6EN

  • 0207 183 5059
We use cookies to provide you with the best possible browsing experience on our website. You can find out more below.
Cookies are small text files that can be used by websites to make a user's experience more efficient. The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
ResolutionUsed to ensure the correct version of the site is displayed to your device.
SessionUsed to track your user session on our website.

More Details