Regulatory Affairs Senior Manager - EU

2018-10-16 09:44:492018-11-13LinkField Life Sciences
Job TypePermanent
AreaCentral London, UK
SectorPharma / Biotech
Salary£ 65,000 ~ 75,000 Annual Rate
Job Ref0065800000Y4jXMAAZ
Job Views845
Description

A cutting-edge biotech working on products to treat cancer using cellular immunotherapy. With three products in phase I and II and a further five products in pre-clinical stages, they looking for a Regulatory Affairs Senior Manager with strong drug development experience. 


Responsibilities


  • Prepare and submit clinical trial applications, substantial amendments, regulatory responses, orphan drug designation requests and maintenance, PIPs, and MAAs to meet company goals and timelines. Must be able to write significant sections of regulatory submissions with input from internal teams and consultants. 
  • Schedule, prepare meeting packages for, and coordinate scientific advice meetings with regulatory authorities.
  • Represent regulatory affairs function within cross-functional product development teams. 
  • Act as a company expert in EU Regulatory Affairs, providing updates, support and education as required.
  • Act as primary contact to EU regulatory authorities.
  • Review all regulatory agency compliance materials to guarantee accuracy, timeliness, comprehensiveness, and adherence to regulatory standards.
  • Maintain current knowledge of relevant EU regulations including proposed and final rules and communicate changes to internal team.
  • Liaise with external collaborators and manage external resources e.g. CROs, consultants
  • Contribute to the global regulatory function and organisation of company regulatory data (SOPs, trackers, templates, etc).
  • Play an instrumental role in the global regulatory affairs function through active participation and collaboration
  • Involved with development of regulatory strategies for new products.
  • Provide regulatory input on other company activities such as pharmacovigilance, medical affairs, risk management, company brochures, and due diligence.


For further information please contact Natalie Hopkins on 0207 183 5059 or email 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