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MANAGER REGULATORY AFFAIRS

LOCATION

London, UK

EMPLOYMENT TYPE

Permanent

Posting Date: 15.01.2024

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We are seeking a Manager Regulatory Affairs to join a growing team in an award-winning regulatory consultancy. This is a full-time, permanent role based in London, UK.
 

This role will be giving guidance to a range of projects for both products in development and marketed products. The role will support global submissions and manage a small team of direct reports.

Our client provides regulatory consulting services to a number of international biotech and pharma organizations across multiple therapeutic areas and across the life cycle.
 

Key responsibilities:

  • Lead a small team of experienced Regulatory Affairs Consultants supporting the timely submission of a variety of projects – CTAs, new MAA/BLA/NDAs as well as post-marketing submissions.

  • Lead the preparation of responses to health authority questions.

  • Provides input and collaborates with the relevant stakeholders on implementing strategies, meeting requirements and timelines.

  • Assists with the development of standards and maintains current knowledge of rules, regulations to ensure compliance and proactively identify any regulatory gaps.
     

Requirements:

  • Scientific background, BS or an advanced degree level in a scientific discipline.

  • 5+ years of Regulatory Affairs experience across the whole life cycle.

  • Prior experience leading a team is a plus.

  • Excellent written and verbal communication skills.

  • Excellent planning and organisational skills with proven record of being able to meet tight deadlines.
     

This role will appeal to a versatile and all-rounded Regulatory Affairs specialist, who is ready to take on the challenge of managing a small team of 5-6 direct reports, while still being hands on with leading projects. Our client offers a competitive salary and an opportunity to work from home.
 

If you are looking for your next career step and this opportunity sounds interesting, then get in touch for more information. Click on the apply button below to send us your CV or to register your interest.

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