UK Regulatory Affairs Consultant

Job title: Regulatory Affairs Consultant - Contract

A Neurology/Immunology Pharmaceutical Company based in Berkshire are seeking a Regulatory Affairs Consultant to join on a contract basis. This opportunity will work across a range of products at all stages of the lifecycle. Initially this will be a UK focused role but there will be scope to support EU/Global projects further down the line. Candidates must have UK Regulatory Strategy experience.

Responsibilities:

• Evaluate relevant UK regulations and guidelines and the BREXIT process critically for their impact on new drug development activities/marketed product
• Develop and advise on local contingency plans for assigned investigational/development projects.
• Support the Global and EU regulatory lead for the delivery of timely approvals and product information
• Lead the planning, preparation and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
• Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents

Requirements:

• Minimum of 5 years of Regulatory Affairs experience within biotech/pharma industry
• Proven experience of biologic and pharmaceutical product submissions.
• In-depth knowledge of the drug development, CTA, product registration processes and the MHRA.
• Demonstrated experience preparing chemistry, preclinical and clinical CTA submissions.

This opportunity is open to PAYE, Umbrella or Limited Company contractors. A competitive hourly rate is on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk

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