Regulatory Affairs Specialist
3 weeks ago
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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