Description
The successful candidate will be responsible for regulatory activities to support and grow the business in line with the company goals. You will be expected to- Obtain and maintain marketing authorisations (MAA)
- Ensure fast introduction of new products and line extensions
- Ensure regulatory compliance
- Streamline regualtory activities with other internal business partners to ensure efficient regulatory processes
- Contribute to influencing positive changes to the regulatory environment
- Coach junior colleagues on regulatory activities
- Lead the standardisation and creation of new systems and processes, and streamlining activities to ensure efficiency gains and to support business continuity
- Prepare and submit regulatory submissions with support as required from Regulatory Support Services
- Provide regulatory strategic input and status of submissions by participation in internal working groups
- Monitor deadlines to ensure project deadlines are met or escalated to Head of Regulatory Affairs
- Advise the Labelling Change & Quality Manager of any changes to labelling and packaging in line with current registered authorization details in order to maintain product compliance
- Contribute to compliance with all regulatory requirements
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Maintain an awareness of regulatory guidelines/directives/national requirements in order to
provide appropriate advice to internal stakeholders and maintain appropriate knowledge levels within the team
Experience:
- Significant Regulatory Affairs experience at both operational and strategic level
- Direct experience and strong knowledge of general regulatory requirements and guidelines, particularly with UK markets (MHRA)
- University Degree in Pharmacy, Biology, Chemistry or a related Life Science
- Member of The Organisation for Professionals in Regulatory Affairs