One of the world's largest and most innovative biotech organizations is looking for an experienced Temporary Regulatory Specialist (pharmaceutical).

This is a 12-month interim contract offering up to £72 p/h with multiple possible working locations around the UK.

You will Lead regulatory submissions and design comprehensive regulatory strategies on biologics/pharma projects by interacting effectively within a cross-functional project team of internal and external subject matter experts. The scope of regulatory submissions will focus on Chemistry and manufacturing Controls. Provide regulatory input into change controls.

Responsibilities:

• Lead regulatory submission teams on biologics/pharma projects to meet the Company's
  product launch/change implementation timelines, including drafting, reviewing, editing, and
  compiling submission documents.
• Work closely with biologics/pharma project teams and regional regulatory representatives
  to develop regulatory- Chemistry and manufacturing Controls strategies and define the corresponding
  submission deliverables. Demonstrates deep knowledge of Chemistry and manufacturing Controls regulatory requirements for biologics and pharma products.
• Assesses the regulatory impact of changes in biologics/pharma product specifications,
  manufacturing process, labeling, and other changes to ensure compliance with EU requirements, including compliance.

Requirements:

• 7-10 years experience in the pharmaceutical industry
• 7-10 years in biologics /pharma submissions experience
• Global regulatory submissions experience preferred, especially in the EU
• Experience with cGMP, GDP, GDocP

This is an extremely urgent requirement so if it is of interest please apply immediately and contact Jamie.mackinlay@1st-executive.com to find out more.