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Regulatory Affairs

2 months ago

London, United Kingdom Meet Full time

Global Regulatory Affairs Associate
Preparing submissions of license variations, assisting in preparation of regulatory documents, acting as a submission specialist will all be core components of this role

The Regulatory Affairs Associate will be responsible for assisting in the preparation and submission of regulatory documents to regulatory agencies. He/she will ensure compliance with applicable regulations and standards.

Assist with the preparation and submission of regulatory documents to regulatory agencies
Assist in the preparation and submission of responses to regulatory agency inquiries
Ensure compliance with regulatory requirements and guidelines
Monitor and update regulatory documentation as necessary to keep company in compliance from a regulatory perspective
Participate in meetings with regulatory agencies as needed
Advise manufacturers on regulatory requirements
Document and track regulatory submissions and regulatory authority approval
Is responsible for review, proof reading and approval of artwork of packaging materials to ensure compliance with regulatory requirements
Is responsible for the preparation of Summary of Product Characteristics, Patient Information Leaflets and labelling according to the Quality Review Documents (QRD) format
Provide on-going regulatory support to the Regulatory Affairs Manager(s) and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
Scientific background is a must – master’s degree in pharmaceutics, health care, life sciences or related fields preferred
~Excellent planning and time management skills
~ Fluent communication skills in English (written and oral), also in Dutch is an asset.
~ English language skills (spoken and written), Dutch is a bonus
Ability to work concurrently on projects, each with specific instructions that may differ from project to project