Job Title: Regulatory Affairs Specialist
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The role of a Regulatory Affairs Specialist is key in ensuring compliance with regulatory requirements for pharmaceutical products. This position involves working closely with the development, manufacturing and commercial teams to ensure that all products are in line with regulatory standards.
Responsibilities will include preparing and maintaining high-quality dossiers, submitting CPP/Manufacturing authorisation requests to health authorities, reviewing data intended for submission and advising on any deficiencies or issues, and ensuring on-time submissions for all quality/safety related changes for assigned projects.
This specialist will also be responsible for preparing and submitting translated texts to EU/non-EU countries, updating databases and systems for all products in line with current SOPs, liaising with third parties where required to establish effective communication and relationships to progress regulatory activities, and liaising closely with business development, product launch, artwork, supply chain and quality colleagues to ensure alignment in all initiatives.
Key skills and experience requirements for this role include a Master's/Bachelor's degree or equivalent in science/technology/pharmacy, minimum 5 years of experience in regulatory affairs, capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions, strong interpersonal and communication skills, experience in dealing with multiple stakeholders both internal and external, and excellent critical thinking and problem-solving abilities.
In addition to these skills, the ideal candidate will be able to work effectively as part of a team, possess excellent time management and organisation skills, and be able to maintain an awareness of regulatory requirements including legislation, guidelines and industry best practice.