Regulatory Affairs Associate
The Regulatory Affairs Associate will be responsible for:
• Managing the clinical trial applications in Europe and other selected countries
• Keeping up to date with regulatory and legal changes in EU
• Preparing pre- and post-authorisation regulatory documentation and applications
• Assisting in marketing access activities including pricing/contracts/product listings
• Providing general regulatory advice to company's staff
Based in the UK, the Regulatory Affairs Associate is expected to;
• Prepare and/or collate all documentation to support clinical trial applications in Europe and other selected countries in close cooperation with the Clinical department,
• Submit applications to competent authorities and ethics committees in Europe and other selected countries,
• Prepare responses to questions raised by ethics committees and competent authorities and update documentation as required,
• Manage the labelling of investigational medicinal product in compliance with regulatory labelling requirements,
• Obtain approval for clinical trials,
• File substantial amendments as required,
• Assist with updating the Investigator Brochure and Investigational Medicinal Product Dossier
Assist in the development of the ongoing global regulatory strategy
• Submissions of marketing authorisation applications and variations
• Prepare response to questions raised by competent authorities
• Applications and submissions to national regulatory authorities as required
• Submissions following post approval obligations and commitments
• Maintain all approvals current by submitting annual updates as needed
ESSENTIAL REQUIREMENTS FOR ROLE
• Post-graduate qualifications in Pharmacy, Biological Sciences, or related disciplines.
• Pharmaceutical industry experience
• Preparation of clinical trial applications
• High level of personal integrity and ethical behaviour
• Strong attention to detail and time management
• Strong written and communication skills