Regulatory Affairs CMC Manager - Biologics

2019-02-27 20:00:082019-03-27LinkField Life Sciences
Job TypePermanent
AreaNorth London, UK
SectorPharma / Biotech
Salary£ 60,000 ~ 70,000 Annual Rate
Job Ref0064I00000rzyBGQAY
Job Views506
Description

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. 


Responsibilities: 

·      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 natalie@linkfieldgroup.com

Apply Later
Sign in
Register
Apply
Later
Register with
Natalie Hopkins
Recruitment Director
Browse Natalie's jobs
View Natalie's bio
Get in touch with Natalie
0207 183 5059
Similar Jobs
  • Global Regulatory Manager - Contract
    UK, London, Central London
    Pharma / Biotech
    £ 60 ~ 70 Hourly Rate

    We are currently partnering with a Global pharma company who are looking for a Global Regulatory Manager to work on a mixture of Emerging Markets and EU Post Marketing activities. The selected professional will be a confident leader who is comfortable working on a variety of products and projects. ...
  • Regulatory Affairs Manager – Medicines
    UK, London, North London
    Pharma / Biotech
    £ 0 ~ 0 Competitive

    Regulatory Affairs Manager – Medicines Location: Hertfordshire (option for 1 day home working)Salary: Competitive Annual Salary + 25 days holiday, Life Assurance, leave early on a Friday, Pension Scheme, Buy and Sell Annual leave, Non-Contractual Annual Bonus We are currently working with a growi...
  • Senior Regulatory Affairs Officer
    UK, Greater London
    Pharma / Biotech
    £ 40,000 ~ 45,000 Competitive

    This a new position in a growing Regulatory team with one of our key partners. The role:Obtaining new and maintaining existing Marketing AuthorisationsMaintaining regulatory activities related to one or more new drug applicationsMaintaining drug licences for designated products in a designated terri...
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:

WE’RE EASY TO FIND

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

  • 0207 183 5059
  • info@linkfieldgroup.com
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
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.
essential
SessionUsed to track your user session on our website.
essential

More Details