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Regulatory Affairs Manager
3 months ago
Are you interested in joining a fast-growing UK Pharmaceutical company dedicated to enhancing patients' lives worldwide?
Role Overview:
- Regulatory Information Management:
- Lead regulatory submissions for medicines, medical devices, and other products, ensuring high quality and professionalism.
- Review and support new product submissions and maintain regulatory documentation.
- Manage technical documentation alignment with regulations and oversee internal regulatory information sources.
- Regulatory Strategy and Writing:
- Provide regulatory expertise to R&D teams, lead regulatory strategy discussions, and justify decisions during product development.
- Present scientific arguments and risk assessments for regulatory procedures and product quality issues.
- Project Management and Compliance:
- Assign and oversee project workload, maintain compliance with current regulations and drive necessary changes.
- Manage artwork processes, regulatory intelligence, line management, and ensure team compliance with SOPs and quality policies.
Requirements:
- Degree in life sciences or chemistry.
- 5+ years of UK and EU pharmaceutical regulatory experience.
- Experience in line management and regulatory leadership.
- Proficient in MS Word, Excel, and PowerPoint.
- Organized, detail-oriented, independent, problem-solver with strong communication skills.
Why Choose Us?
- Competitive Salary & Benefits.
- Pension Scheme and Life Assurance.
- 25 days holiday plus Bank Holidays.
- Learning & Development Opportunities.
- Company Events and Celebrations.
