Temporary Regulatory Specialist
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Location
England
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Sector:
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Job type:
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Salary:
£50 - £72 per hour
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Contact:
Jamie Mackinlay
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Contact email:
jamie.mackinlay@1st-executive.com
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Salary high:
72
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Salary low:
50
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Job ref:
JM028_1616002262
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Published:
about 3 years ago
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Duration:
12 months
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Expiry date:
2021-04-16
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Startdate:
ASAP
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Consultant:
ConsultantDrop
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.