Title of Post: / Regulatory Affairs Project manager
Location: / Regulatory Affairs, BPL, Elstree.
Category / Description / Essential / Desirable / Assessment Method
Skills &
Abilities / RA Project management skills
Good analytical skills to identify best strategy
Excellent communication skills in English
  • in order to verbally and in writing explain the regulatory submission strategy incl. time line risks
  • to keep the right people updated about business critical matters
  • general presentations
Analytical mind/critical review skills to ensure good quality submissions
Keen eye for detail
Good negotiation skills
Proficient in use of Microsoft Office suite
Ability to work within cross-functional teams / √
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Knowledge & Experience / Min of 8years’ experience in a Regulatory Affairs functionincluding hands-on licencing activitiesexperience.
RA experience with
  • Orphan drugs. Classification and licencing (must)
  • Biologicals (must)
  • Plasma derived products (added bonus)
Full knowledge of ICH and all aspects of an ICH CTD incl regulatory intelligence savvy
Thorough experience with EU requirements and procedures (CEN, DCP, MRP, National) for all stages from drug development to final approval and product launch. Incl
  • pre-submission meetings with Health Authorities
  • Mod 1-5 Dossier requirements
  • Post Marketing Commitments
  • Change control, change classification & variation management
  • launch preparation & promotional material
Experience of managing Biologics Licence Applications to the USFDA from strategy development to final approval and product launch.
  • Basics (must)
  • Experienced (added bonus)
Experience of managing FDA post approval changes
  • Basics (must)
  • Experienced (added bonus)
Experience of managing Biologics Licence Applications to the US FDA from strategy development to final approval and product launch.
•Basics (must)
•Experienced (added bonus)
Experience in obtaining and maintaining clinical trial authorisations in the US, EU and Intercontinental region
  • Basics (must)
  • Experienced (added bonus)
Experience of dealing directly with Health Authority assessors.
  • Suggesting, planning, coordinate/write a proper brief, attend, decision minutes
Knowledge of current USA, FDA legislation and guidance for licensing of biological products.
Knowledge or experience of generating eCTD documentation packages.
Experience with Paediatric data requirements for licensing. / √
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Training &
Education / First degree in Life Sciences. (added bonus:Msc, PhD)
RA degree (TOPRA, DEGRA, MEGRA)
Regular attendance at relevant Regulatory Affairs conferences and training (DIA, TOPRA, PPTA, RAPS) / √
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Other Requirements / Own transport.
May need to travel to travel within and outside the UK / √
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H:\D05\DATA\PERS\Recruitment\Job Descriptions\Technical\Regulatory Affairs\Regulatory Affairs Project Manager ps.doc