Regulatory Affairs Specialist

3 weeks ago


Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time

About the Role

We are seeking a highly skilled Regulatory Affairs Officer to join our team in the UK. As a key member of our regulatory affairs function, you will play a critical role in ensuring compliance with EU regulations and standards.

The successful candidate will have at least 7 years of experience in regulatory affairs within the pharmaceutical industry, a life science degree, and excellent communication skills. If you are passionate about delivering high-quality results and driving business growth, we encourage you to apply for this exciting opportunity.

Key Responsibilities

  • Manage regulatory affairs for UK & EU products within our portfolio, ensuring adherence to relevant regulations and standards.
  • Conduct thorough assessments of Marketing Authorisation (MA) versus manufacturing documents to identify and address any discrepancies.
  • Lead the preparation and submission of new Marketing Authorisation applications in the EU through various routes including National, Mutual Recognition, and Decentralised Procedures.
  • Drive the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards.

About Us

Ethypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs. We are committed to improving patients' lives and making a positive impact on society and the environment.

Our estimated salary range for this position is £60,000 - £80,000 per annum, depending on experience. We offer a comprehensive benefits package, including health insurance, pension scheme, and professional development opportunities.

Requirements

  • Regulatory experience in the pharmaceutical industry minimum 7 years.
  • Life science degree.
  • Excellent planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation whilst maintaining attention to detail.


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