Senior Regulatory Affairs Manager - Clinical Stage Biotech

2019-02-27 20:00:082020-03-16LinkField Life Sciences
Job TypePermanent
AreaNorth London, UK
SectorPharma / Biotech
Salary£ 65,000 ~ 70,000 Annual Rate
Job Ref0064I00000rzyB1QAI
Job Views1357

We are currently partnering with an exciting clinical-stage Biotechnology company looking to hire a Senior Regulatory Manager to work alongside the Regulatory Affairs Senior Director. This is a truly ground breaking company with a patient centric approach. The successful candidate will participate in the development and implementation of regulatory strategy for specific programmes. 

Office Location:

Hertfordshire with the flexibility for 2 – 3 days a week working from home if desired. 


·       To design the execution of certain regulatory activities/submissions necessary to support global product development and registration 

·       Support regulatory sub-team and product development teams in all aspects of regulatory affairs, both strategic and operational 

·       Ensuring preparation of high-quality regulatory documents including, but not limited to, IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings to support regulatory compliance. 

·       Act as contact point for internal and external clients, including CROs and regulatory authorities 

·       Help with training of staff in regulatory matters. 

·       Extensive project management activities across Regulatory Affairs 

Education / Requirements: 

·       Relevant degree in a life science / science discipline. 

·       Previous Regulatory Affairs experience working on early phase products 

·       Rare disease / Orphan Drug applications experience is preferred but not essential 

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 Associate Director - EU Established Products
    UK, London, Central London
    Pharma / Biotech
    £ 70,000 ~ 80,000 Competitive

    Working as part of an evolving Regulatory group, this EU leadership role will combine hands on technical project work and team management. You will provide a regulatory strategic focus for lifecycle management including variations / amendments, renewals, line extensions / MAAs.


  • Global Regulatory Lead - 8 month contract - £70 per hour
    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 Lead to work on their Established products portfolio covering Global Markets.

    This 8 month contract will involve undertaking a range of post marketing activities across Global regions...

  • Senior Regulatory Manager / Associate Director - Oncology - Biot
    UK, London, West London
    Pharma / Biotech
    £ 70,000 ~ 80,000 Competitive

    We are currently partnering with an Oncology Biopharmaceutical company who are developing novel cancer immunotherapies (previous ATMP / Cell Therapy experience is NOT a prerequisite for this position although would be an added bonus). 

    We are looking for an experienced Regulator...

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