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Regulatory Executive

Posted 5 March by B&S Group Easy Apply Ended

SALARY AND BENEFITS: Negotiable

REPORTS TO: Regulatory Manager

Department: Parallel Imports

LOCATION: Ruislip

The B & S Group is a privately owned pharmaceutical company which manufactures and distributes pharmaceutical and healthcare products to the UK market. Established in 1999 we offer a wide range of products and services which includes specials, generic drugs, branded medicines, parallel trade and over-the-counter (OTC) medicines. Having undergone two acquisitions since 2010, we are continuing to strengthen and grow.

PRIMARY RESPONSIBILITIES

  • To write and review high quality documents for submission to National and EU Regulatory Health Authorities
  • Write and review responses to the Health Authority
  • Liaise and co-ordinate with affiliates for preparation of submission
  • Pro-actively work with various departments to ensure submission dates are met

SECONDARY RESPONSIBILITIES

  • Parallel imports licensing work for MHRA, IMB and EMA
  • To prepare documents for applications, renewals and variations from start to end
  • Responding to the queries received from the regulatory bodies (MHRA, IMB and EMA) in a timely manner
  • Performing monthly in-house tasks for licence update and audit
  • Administration duties: Scanning samples and documents; Filing and archiving including maintenance of Products, documents and logs
  • Ad hoc duties as and when required

ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES

  • Life Science Degree or equivalent
  • Must have some understanding on MHRA and EU Regulatory Requirements
  • Experience with EU Regulatory would be ideal
  • Knowledge of pharmaceutical products will be an added advantage
  • Proactive attitude
  • Good written and oral communication in English
  • Ability to manage, organize and priorities work
  • High attention to detail
  • Ability to work on own initiative and work as a team
  • Working knowledge of MS Office
  • Ability to adapt to change

Required skills

  • EMA
  • EU
  • Pharmaceutical
  • MHRA
  • UK market

Reference: 33769015

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