Service Provider to the Pharmaceutical Industry Requires a Regulatory expert to Join their dynamic team as a Labeling Strategist, ensuring regulatory excellence in the pharmaceutical industry.
Responsibilities and Experience:
- Hold a Bachelor's degree in a scientific discipline with 9 years' experience in Regulatory Affairs Labeling or a highly regulated environment.
- Develop and revise CCDS, US, and EU labeling for mature and lifecycle products, obtaining company and agency approval.
- Coordinate end-to-end labeling review, approval, and submission to regulatory agencies, negotiating product approvals or updates.
- Provide strategic guidance on complex labeling projects, leading a multidisciplinary labeling working group.
- Collaborate with associates and management globally, demonstrating excellent communication and organisational skills.
- Anticipate and minimise implementation hurdles, ensuring compliance with regulatory requirements.
- Lead regulatory strategy into labeling strategy, proficiently presenting to senior management.
- Highly detail-oriented with strong analytical, leadership, and project management skills.
Interested? Send your resume to me or contact 020 7940 1212 to explore this exciting opportunity