Global Head of Regulatory Operations
Healthcare Company - South West London
Our client is a well-established healthcare company with a strong product portfolio spanning a number of years. Due to continued growth in the business we are now looking for a Global Head of Regulatory Operations to join the business.
The role will involve setting the strategic direction for Regulatory Operations and provide leadership for the Regulatory teams across the world. You will ensure that products are compliant to all applicable regulations globally and develop corporate regulatory policies and procedures and ensure zones understand and implement the policies and procedures at a local/regional level.
- Determines the strategic direction for Regulatory Operations and sets objectives for the Regulatory Operations teams
- Maintains close contact with the Regulatory Operations teams in each zone, to ensure a consistent approach is used and to build teamwork between the teams.
- Ensures that product licenses, registrations and notifications are prepared and submitted to the relevant Regulatory Authorities.
- Maintain a global database of product data related to registrations, licensing and notifications for lead markets in each zone.
- Ensures that artwork and product labelling is approved to ensure compliance to regulations.
- Ensures that product claims used on advertising and promotional material are reviewed and approved in accordance with legislation and codes of practice, and ensures sufficient substantiation is available, as required by local regulations.
- Provides regulatory advice to the Marketing and Commercial functions.
- Implements key performance metrics to maintain focus on compliance across the business.
- Participates in New Product Development projects, providing regulatory advice to ensure that the introduction of new products is in accordance with regulations.
- Co-ordinates the work of Regulatory consultants as required.
- Builds relationships with Regulators and relevant Industry Associations.
- Ensures that the Quality and Regulatory Officer in the US identifies and manages adverse events (AE’s), reporting serious AE’s as required by the FDA.
Degree in relevant subject.
- Minimum 5 years’ experience in a Regulatory role in pharma or healthcare.
- Knowledge of the regulatory requirements in EU and US
- Understanding of product claims allowed in EU and US
- Experience in working with Regulatory Authorities, including MHRA, on product licensing, data submissions and reporting issues as required.
- Experience in developing and implementing Regulatory policies and procedures to ensure compliance to applicable regulations and GxP standards.
Skills and Abilities
- Good leadership and influencing skills to build a culture of compliance across the organisation.
- Ability to drive improvement and make changes to existing working practices.
- Professional, confident, bright, ability to work on own initiative, self motivated.
- Excellent written and oral communication skills.
- Pragmatic and able to work under pressure and adhere to deadlines.
- Promotes enthusiastic approach to compliance by helping and educating colleagues.
- Pragmatic and able to work under pressure while maintaining focus on consumer/patient safety and compliance to regulations.
- Empathy for commercial realities and able to articulate risk and consequence of regulatory compliance.
- Pro-active and uses initiative to resolve issues.
Key words regulatory, quality, FDA, GMP, manager, head of
Harris Lord is acting as a recruitment agent for the purposes of this role