Regulatory Affairs Lead Role
We are seeking an experienced Regulatory Affairs Director to lead our regulatory efforts in a dynamic and fast-paced environment. This is an excellent opportunity for a professional with a strong background in regulatory affairs, who is passionate about driving business growth and improving compliance.
About the Role
This role will play a pivotal part in ensuring that our regulatory strategies align with our business objectives, while maintaining the highest standards of professionalism and quality.
Your Key Responsibilities
- Serve as the primary point of contact for critical regulatory matters
- Manage a team of Regulatory Affairs professionals, including direct reports and subject matter experts
- Lead interactions and formal communications with governmental agencies (e.g., EMA, FDA) to support regulatory submissions and negotiations
- Participate in departmental budget planning and execution
- Responsible for setting and tracking key performance indicators aligned to department and corporate goals
Your Qualifications
Masters degree in Science or related field required
- Experience with at least one major marketing application
- In-depth knowledge of evolving regulatory requirement trends and guidance
- Good understanding of complex biologics manufacturing science
- Familiarity with CMC terminologies
- Excellent project management skills, including planning, organizing, and motivating others
- Minimum of 10 years pharmaceutical industry experience in R&D, Regulatory CMC, or related functions
- Strong technical aptitude, including reading and executing procedures
Benefits
- Bonus scheme
- Parking available
- Pension plan
- Access to sports and social club facilities
- VHI health insurance
About Us
We are a global leader in the biologics services provider, dedicated to accelerating and transforming discovery, development, and manufacturing in the fast-growing field of biologics. Our mission is to benefit patients worldwide by delivering innovative solutions and exceptional service.