Overview

Reference Number: JO-2010-455666
Regulatory Submissions Technical Advisor
Rate: Negotiable
Job Type: Permanent
Location: Central London / West End

Role: Regulatory Submissions Technical Advisor
Location: central London
Salary: competitive + benefits
employment: full time, permanent

Regulatory Professionals are collaborating with a midsize, clinical contract research organization. They provide services for Phase I-IV of drug and medical device development services including regulatory services and central laboratory services. Our client is seeking a regulatory affairs professional who has a strong understanding of regulatory documentation, guidelines and legislations and be able to develop proactive solutions to regulatory issues and challenges in particular in order to provide strategic guidance to the Regulatory Submissions Manager.

Other duties will include:

  • Offer regulatory submissions strategic advice and guidance to the Regulatory Submissions Manager (RSM), project team, and Sponsor to ensure submissions compliance with appropriate regulations and requirements
  • Prepare and/or review core trial documents for compliance with relevant guidelines/regulations and for trial suitability
  • Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
  • Self-sufficiently interact with Sponsors, regulatory agencies and colleagues; and
  • Present during bid defences other projects and responsibilities as assigned.

Knowledge & Skills

  • Right to work in the UK
  • Bachelor’s degree in Life Sciences – Master’s/PhD preferred
  • Significant experience in clinical research, preferably with a CRO;
  • Strong understanding of regulatory documentation, guidelines and legislation;
  • Ability to review regulatory guidance and develop proactive solutions to regulatory issues and challenges
  • Experience in reviewing and/or writing core regulatory documents;
  • Strong communication, critical thinking, and problem-solving skills
  • Ability to independently interact with national/regional regulatory agencies.

 If you would like to apply for this position, please contact Amani via amani.yousef@regulatoryprofessionals.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you £250 worth of vouchers *terms and conditions apply*