Regulatory Affairs Senior Associate / Associate Manager - CTA

2018-10-16 09:44:492018-11-13LinkField Life Sciences
Job TypePermanent
AreaNorth London, UK
SectorPharma / Biotech
Salary£ 40,000 ~ 52,000 Annual Rate
Job Ref0065800000UVO7HAAX
Job Views284
Description

Based at a growing organisation, working on a wide scope of products and therapy areas, this key partner of ours is looking for a Regulatory professional with strong CTA experience.

 

  • Responsibilities:Prepare and submit Clinical Trial Authorisation (CTA) applications and substantial amendments to competent authorities throughout Europe.
  • Assist with managing workload of clinical trial team and prioritisation decisions.Review and extract information from clinical trial associated documentation (incl. IMPDs, IBs, EudraCT, Protocols & labelling)
  • Quality control check junior member of staff work and contribute to their training. 
  • ExperienceGraduate in relevant scientific discipline
  • Broad Regulatory CTA experience covering a range of EU countries 
  • Experience in preparing submissions for both competent authority and ethics committees.
  • Experience with IRAS system and HRA process for UK submissions.
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Good computer skill
  • Self-motivated with excellent communication skills
  • Strong attention to detail

Reports to: Regulatory Affairs Senior Manager


For further information 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