Pharmaceutical Regulatory Affairs Manager

22 hours ago


London, Greater London, United Kingdom B&S Group Full time
Job Overview

We are seeking a seasoned Pharmaceutical Regulatory Affairs Manager to join our team at the B&S Group. As a key member of our regulatory affairs department, you will be responsible for managing the preparation and review of dossiers for MA variation applications, MA renewals, and other regulatory post-licensing submissions.

The successful candidate will have at least 6 years of relevant experience in the pharmaceutical industry, with a strong understanding of EU directives, ICH guidelines, and UK requirements. You will be responsible for developing and maintaining SOPs, change controls, and internal processes to ensure regulatory compliance. Your excellent communication skills will enable you to liaise effectively with regulatory authorities, internal teams, and external partners.

About the Role:

  • Develop and maintain SOPs, change controls, and internal processes to ensure regulatory compliance
  • Liaise with regulatory authorities, internal teams, and external partners to resolve issues and implement changes
  • Manage regulatory dossiers and submissions to ensure timely and compliant delivery
  • Train junior members of the regulatory department on best practices and procedures

Requirements:

  • Bachelor's degree, Master's degree, or Ph.D. in a relevant field
  • At least 6 years of experience in pharmaceutical regulatory affairs, with a strong understanding of EU directives, ICH guidelines, and UK requirements
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team

Estimated Salary: £70,000 - £85,000 per annum, depending on experience and location. We offer a competitive benefits package, including a bonus scheme, pension plan, and opportunities for professional development.



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