Regulatory Affairs Specialist - Small Team, Awesome Exposure

Posted 1 November by NonStop Recruitment
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NonStop are currently partnered with a small, private pharmaceutical company that creates, develops and improves speciality medicinal products to recruit for a full time/ part-time Regulatory Affairs Specialist to join their team.

Where this position stands out from the rest of the market is the size of the team, with circa 20 people in the company and just 1 current Regulatory specialist. This means the ideal candidate will need to be adaptable to all areas of Regulatory and will in turn receive great exposure.

Based out of their North London office with potentially some flexibility for working from home, you will carry out a range of regulatory activities with a focus on centralised applications.

The ideal candidate will have experience in EU post authorisation life-cycle maintenance, including management of product information, and an understanding of pharmacovigilance.

General pharmaceutical development knowledge and experience of clinical trial applications would also be of relevance.

This role will suit someone who wants to join a small hard-working team and take a proactive role in all aspects of regulatory affairs.

Responsibilities:
* Manage the life-cycle maintenance of existing MAs
* Review and quality check regulatory dossiers (marketing and clinical trial stage) and documents (eg, protocols, IBs, PSMF, PSUR)
* Preparation of responses to questions from Regulatory Agencies
* Oversight of contracted out pharmacovigilance activities
* Preparation, maintenance and quality check of Product Information e.g. SmPC, PIL, labelling, artwork
* Ensure projects are conducted in accordance with the latest ICH-GXP guidelines and legislation

Skills / experience required:

Essential:
* Degree in Life Sciences
* 5 years UK/EU regulatory affairs experience
* Experience of EU authorisation procedures
* Fluent in both verbal and written English
* Meticulous attention to detail
* Adaptable and flexible within a team

Desired:
* Proven record as an accomplished Regulatory Affairs Associate
* Experience of EU central authorisation procedures
* Experience of US regulatory procedures/documentation
* Language skills in other European languages
* Excellent communication and time management skills
* Demonstrable track record for effective relationship building with colleagues and external collaborators, in addition to strong management skills.

For a confidential discussion about this, please contact Edward Little on (EXT: 7168) or send your updated CV in a word document to

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Required skills

  • Artwork
  • Regulatory Affairs
  • Labelling
  • pharmaceutical
  • pharmaceuticals
  • cmc
  • pharma
  • bioscience
  • lifecycle
  • reg affairs
  • post marketing
  • regs
  • chemical manufacture control

Reference: 39271533

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