12 months ago
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.
- 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
- 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 firstname.lastname@example.org