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Regulatory Affairs Associate

4 months ago

England, United Kingdom EPM Scientific Full time

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,

• 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

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