Senior Regulatory Submissions Analyst (publishing)

Location
Buckinghamshire (GB) and Home working
Salary
Competitive salary and benefits
Posted
08 Jan 2021
Closes
07 Feb 2021
Ref
0801SRSAP
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

DETAILS:

  • Full-time contract position
  • ASAP start for minimum 12 month contract
  • Remote working initially with some office travel to Buckinghamshire
  • Competitive package available
  • Global pharma company

 

THE ROLE:

  • Publishes submissions within the European Region in line with current national and regional requirements for eCTD applications.
  • Works with regional archivists to ensure that published submissions are archived in accordance with local and global SOPs.
  • Provides guidance (and where necessary training) to European Region Regulatory Affairs staff on all aspects of submission formats/requirements and publishing related software/tools as and when required.
  • Builds and maintains relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of regulatory submission strategy and activities.
  • Works collaboratively with colleagues within the International Regulatory Submissions Team across the AMEA, Europe and LACAN regions.
  • Provides support and mentorship to junior colleagues within the team

Full job description available on application

 

THE CANDIDATE:

  • Good knowledge of European pharmaceutical regulations and guidelines.
  • Experience in publishing CP, MRP and DCP submissions, including eCTD
  • Good knowledge and experience of all submission types (MAAs, Variations, Renewals, CTAs, ASRs etc)
  • Knowledge/experience in publishing submissions for emerging markets (Middle East, Non-EU Europe etc) would be ideal.
  • Experience in eCTDs an NeeS essential
  • Ideally experience using Liquent
  • Only candidates with existing right to work in the UK/EU will be considered

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.