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Temporary Regulatory Specialist

Temporary Regulatory Specialist

  • Location

    England

  • Sector:

    Supply Chain

  • Job type:

    Contract

  • Salary:

    £50 - £72 per hour

  • Contact:

    Jamie Mackinlay

  • Contact email:

    jamie.mackinlay@1st-executive.com

  • Salary high:

    72

  • Salary low:

    50

  • Job ref:

    JM028_1616002262

  • Published:

    about 2 months ago

  • Duration:

    12 months

  • Expiry date:

    2021-04-16

  • Startdate:

    ASAP

  • Consultant:

    #

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.