Regulatory Affairs Specialist

2 days ago


Huntingdon, Cambridgeshire, United Kingdom Biotalent Full time

About BioTalent:

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BioTalent is a global leader in the pharmaceutical industry, recognized for its dedication to quality, innovation, and customer satisfaction. Our company strives to attract and retain top talent who share our vision and values.

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Job Summary:

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We are seeking a Regulatory Affairs Specialist to support key projects and site growth. As a Qualified Person, you will play a crucial role in driving quality improvements, promoting quality culture, and defining GMP standards.

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Key Responsibilities:

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  • Drive quality improvements across compliance to reduce quality issues and reworks.
  • Promote quality culture across the site by liaising with cross-functional teams.
  • Define GMP quality standards at all times to meet business and customer expectations.
  • Participate in internal and external audits, and support vendor quality management activities.
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Requirements:

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  • Minimum Bachelor's degree in Science or QA discipline.
  • At least 5 years relevant on-the-job work experience as a QP on a manufacturing license.
  • Ability to undertake the duties of a Qualified Person as defined in Directives 2001/83/EC and 2001/20/EC.
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Salary and Benefits:

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The estimated annual salary for this position is $160,000 - $220,000 depending on qualifications and experience. We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

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Location:

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This position is based in a fast-paced global pharmaceutical business with opportunities for growth and development.

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Why Choose BioTalent:

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BioTalent offers a dynamic and supportive work environment, where you can make a real difference in the pharmaceutical industry. If you are passionate about quality and excellence, join our team and take your career to the next level.



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