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Senior Regulatory Affairs Specialist
4 months ago
Title: Senior Regulatory Affairs Specialist
Location: London
Hybrid working
Purpose of Job:
Support the business with regulatory advice and activities to ensure that timely approval and maintenance activities are carried out on time, that all Regulatory and Quality systems are updated and correct, to identify and flag any potential/actual compliance issues and to work effectively within a team of Regulatory Affairs professionals based in the UK and India. Provide guidance and training for junior members of the team.
Experience:
* At least 5 years relevant experience within the Pharmaceutical industry.
* Good understanding of the EU/UK legal and regulatory requirements for the registration and maintenance of medicinal products, including technical knowledge of the content of CTD sections.
* Due Diligence/Compliance review of dossiers and reactivation of dormant licenses.
* Preparation and review of supportive documents required for submission to Health Authorities.
* Experience of interactions with Health Authorities
Key Roles/Responsibilities:
* To review changes to existing licenses and propose strategies for regulatory submissions for existing products in all territories as required by the business.
* To determine the most efficient strategy for regulatory submissions for new projects in all territories as required by the business.
* other Regulatory Affairs colleagues with the preparation and submission of New Applications within the EU and UK and supervise the assigned activities of junior members of the team.
* To review all documents intended for submission to regulatory authorities.
* Carry out assigned regulatory actions and ensure they are completed in a timely manner and in line with project milestones.
* To ensure that all trackers are promptly updated and all communications are shared with the relevant stakeholders upon regulatory approval.
* Ensure regulatory compliance of marketing authorisations with relevant national and European requirements
