Regulatory Affairs Specialist
6 days ago
We are seeking a highly experienced Qualified Person to join our team at SRG, a leading recruitment company specializing in the pharmaceutical and life sciences sectors.
Job Summary: As a Qualified Person, you will be responsible for guiding and advising our clients on regulatory affairs, ensuring compliance with relevant guidelines and regulations.
Main Responsibilities:
- Batch Certification and Release: You will be responsible for certifying and releasing batches of licensed products manufactured on site by our clients, as well as third-party QA audit reports.
- QP Declaration Approval: You will review and approve QP declarations for license submissions.
- Regulatory Compliance: You will ensure that our clients are compliant with relevant regulations, including EU Directive 2001/83/EC, Article 49 and Human Medicines Regulations (as amended), SI 2012/1916, Schedule 7, Part 1.
Requirements:
- Experience: You will have prior experience in a similar role, with a strong understanding of regulatory affairs and compliance.
- Knowledge: You will have a deep understanding of EU Directive 2001/83/EC, Article 49 and Human Medicines Regulations (as amended), SI 2012/1916, Schedule 7, Part 1.
About SRG: We are a specialist recruitment company with a passion for the science and engineering sectors. Our team of experts has a deep understanding of the industries we serve, and we are committed to providing outstanding career opportunities for our candidates and expert recruitment services for our clients.
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