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Regulatory Affairs Officer

Devon   •  33-43K  •  Permanent, Full time


Our client is a well-established pharmaceutical organisation based in South Devon (near Torquay). Due to continuous growth they are currently seeking to recruit a Regulatory Affairs Officer within their Export department.

Job Role

Responsible for international submissions in line with the commercial export strategy & in liaison with the Commercial Team.

Liaison with local agents in identified regions for export expansion to ensure the regulatory and commercial aspects are aligned to enable the quickest route for a successful approval.

Qualifications & Training

  • Degree educated – life sciences degree (hons)
  • Minimum 2 years’ experience of working within the Pharmaceutical Regulatory Industry (Regulatory Consultancy, Regulatory Agency or Pharma Company). Include licensing overseas (e.g. Middle East, Africa, Asia)

Special Experience

  • Experience of licence application submissions via the decentralised and centralised routes within Europe and submissions outside of the EU to global regulatory agencies
  • Working with overseas regulators to co-ordinate the submission processes for export strategies
  • Specialist licensing experience within the Pharmaceutical industry
  • Understanding & experience of Good Manufacturing Practice/Good

Knowledge & Skills

  • Excellent communication and interpersonal skills
  • Experience of presenting complex information to large groups
  • Excellent knowledge of national and international licensing processes & legislation
  • Excellent knowledge of national and international pharmacovigilance legislation
  • Excellent knowledge of medical device certification processes and legislation
  • Excellent organisational skills
  • Ability to work under pressure to meet deadlines/targets
  • Self-motivated
  • Excellent time management
  • Excellent planning and prioritisation skills
  • Ability be work independently with a high level of autonomy and as within a team
  • Able to deal with conflicts in demand, time constraints and deadlines
  • Experience of dealing with confidential and commercially sensitive information
  • Excellent IT skills – use of Adobe Acrobat Professional, eCTD

Personal requirements

  • Self-motivated.
  • Able to deal with conflicts in demand, time constraints and deadlines
  • Ability to project manage several projects simultaneously
  • Excellent written and presentation skills.

Other requirements

Computer/Keyboard skills: Adobe Professional, Prisym, LIMS, Q-Pulse, eCTD Office Complier

Attendance at Competent Authority, Distributor locations (overseas) when required

Attendance on specialist area study days, short courses etc.

Able to deal with conflict in demand, time constraints and deadlines

Ability to communicate delays in licence approvals that may cause commercial delays, business impact

Ability to deal with urgent requests from Regulatory Agencies (national and international) within strict deadlines of a highly complex scientific nature

Able to concentrate for long periods on complex tasks or highly complex technical and clinical information

Ability to work with a level of autonomy alone and use own initiative

Ability to prioritise workloads and timescales

DESIRABLE

Management qualification, TOPRA membership, Chartered status

Experience of working within the Pharmaceutical

Pharmacovigilance Industry

Educated to Masters level / or equivalent experience in relevant area

At least one other language from Middle East,

Africa, Far East – fluent to technical level

Experience of generic manufacturing and branded pharma

To apply for this position, candidates must be eligible to live and work in the UK


You must be eligible to work in the UK. Learn more

  • Agency: ST Recruitment
  • Contact: Sam
  • Phone: 01737 241823
  • Reference: TBR-20
  • Posted: 26th March 2019
  • Expires: 23rd April 2019

ST Recruitment

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