Global Regulatory Affairs Expert
3 weeks ago
We are seeking an experienced Global Regulatory Affairs Expert to join our team at the B&S Group. As a key member of our regulatory affairs department, you will play a vital role in ensuring compliance with pharmaceutical regulations and guidelines.
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 managing the preparation and review of dossiers for MA variation applications, MA renewals, and other regulatory post-licensing submissions. Your excellent communication skills will enable you to liaise effectively with regulatory authorities, internal teams, and external partners.
About the Role:
- Manage regulatory dossiers and submissions to ensure timely and compliant delivery
- Liaise with regulatory authorities, internal teams, and external partners to resolve issues and implement changes
- Develop and maintain SOPs, change controls, and internal processes to ensure regulatory compliance
- 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: £75,000 - £90,000 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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