Senior Regulatory Affairs Manager – Contract

About the role

tranScrip has an excellent reputation for providing strategic regulatory support and for delivering regulatory documents and processes. Our team is growing, and we are searching for highly capable Senior Regulatory Affairs Managers to join us and support our clients.

We are currently looking to increase our pool of freelancers and are specifically interested in those with CTA/CTIS experience.

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Duties and responsibilities

Applicants will have extensive experience in all or most of the following areas:

  • Preparation, submission, and maintenance of Clinical Trial Applications in the EU and UK.
  • Strategic and tactical input in development, post-approval, and lifecycle management projects.
  • Liaison with regulatory agencies, client companies and other stakeholders
  • Schemes such as orphan drug designation, SME status, paediatric. investigation plans, scientific advice, ATMP classification, PRIME, EAMS and ILAP.
  • Marketing Authorization Applications and post-approval procedures.

Key Requirements and Competencies for the Ideal Candidate

Experience

  • In depth knowledge of the regulatory environment, guidelines, and practice within the EU.
  • Experience in the clinical development and/or biotech sectors are particularly desirable.

Qualifications

  • Bachelor’s degree in pharmacy, a life science, or a biomedical discipline.

Personal attributes

  • Excellent English and written and oral communication skills.
  • Excellent project management, organization, and multi-tasking skills.
  • Superb attention to detail and accuracy.
  • Self-motivated, pro-active, and capable of working independently and as part of a team.

Successful applicants will be competent in the following

  • Fostering constructive and professional working relationships with clients.
  • Delivering on projects on time and within budget.
  • Keeping up to date with new or changing regulatory requirements in relevant territories.
  • Managing multiple projects and priorities.

Location

  • The position of Senior Regulatory Affairs Manager will be fully remote based in the UK.

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