Head of Regulatory Affairs
2 months ago
Job Title: Head of Regulatory Affairs
Company: Emporium Human Capital
The Head of Regulatory Affairs holds ultimate responsibility for the OTC division's regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business.
Key Responsibilities:
- Drives the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.
- A adopts a risk-based assessment for all regulatory submissions and formulates regulatory risk mitigation strategies, as applicable.
- Anticipates, communicates, and manages future regulatory changes and impacts on business success.
- Communicates to ensure an excellent understanding of Regulatory Affairs.
- Pays strict attention to detail and accurately monitors and measures progress towards objectives and provides feedback on results while maintaining a sense of urgency.
- Strives to maintain a high level of quality. Ensures superior execution by combining the best regulatory practices.
- Represents RA at operational meetings such as Group Regulatory, Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability, and Research & Development.
- Assists the launch team to facilitate a smooth launch process in line with product and dossier compliance.
Requirements:
- A minimum of 8 years of pharmaceutical regulatory experience is an absolute prerequisite.
- A minimum of 5 years in people or team management is required.
- This role requires a high degree of networking and collaboration both within and outside the organisation.
- Demonstrated experience across the product development, commercialisation, and dossier maintenance lifecycle.
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