Regulatory Affairs Specialist
4 days ago
A Biotech Regulatory Affairs Executive will maintain product licences, submit applications and follow up with regulatory authorities. This role is a great opportunity to join PMLiVE and contribute to the company's mission in a pharmaceutical regulatory environment.
Key Responsibilities:
- Prepare and publish regulatory submissions within eCTD format and update the Regulatory Information Management System (RIMS)
- Prepare responses to questions issued by the Regulatory Authorities
- Follow up with Regulatory Authorities on submissions and regulatory issues
- Write, review and advise on SmPCs and packaging
About You:
To succeed in this role, you should have experience working in a pharmaceutical regulatory/licensing environment, a good understanding of regulatory procedures, and strong IT skills. A competitive salary package (£80,000 - £100,000 per year) will be offered to the successful candidate.
What We Offer:
We are committed to providing a supportive work environment that encourages personal and professional growth. As a member of our team, you can expect a comprehensive benefits package, including health insurance, retirement plan, and generous paid time off.
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