£50 - £72 per hour
about 2 months ago
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.
- 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.
- 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.firstname.lastname@example.org to find out more.