Regulatory Affairs Specialist
7 days ago
MAC Clinical Research is a global Contract Research Organisation (CRO) that provides comprehensive services to the pharmaceutical industry. Our mission is to deliver high-quality research solutions with integrity and honesty, making a significant contribution to human health.
Job SummaryWe are seeking a highly skilled Qualified Person to join our team at MAC Clinical Research. As a Qualified Person, you will play a critical role in ensuring the quality and safety of medicinal products.
Key Responsibilities- Perform the duties of the Qualified Person as described in Article 51 of Directive 2001/83/EC and the applicable UK Statutory Instrument.
- Release Investigational Medicinal Products (IMPs) for use in human clinical trials at MAC Clinical Research facilities, ensuring subject safety.
- Work with and organize the workload of any other contract/trainee QPs employed by MAC.
- Review and approve Technical Quality Agreements.
- Act upon product complaints, deviations, and recalls.
- Ensure the Quality Management System is robust and effectively implemented to support safe IMP manufacture and release.
- Attend regulatory inspections and GMP Sponsor audits as required.
- Perform GMP training to staff as required.
- Undertake Continuing Professional Development as required.
- Maintain personal training and attend training sessions as required.
- Comply with MAC's health and safety policy.
- Comply with MAC's policy on equality and diversity.
- Maintain professional qualifications required for the role, including continuous personal development.
- Work according to MAC SOPs, guidelines, and policies.
- Work according to current data protection standards and practice good information management.
- Maintain strict confidentiality of patient and business-related data.
- Pharmacy, Biological, or Chemical Science degree.
- Member of a recognized professional body (Royal Pharmaceutical Society GB, Royal Society of Chemistry, or Institute of Biology).
- Two or more years' experience of clinical trials within the pharmaceutical industry.
- Experience in a CRO, Phase 1 Unit, or Hospital pharmacy.
- Competitive salary in line with pharmaceutical industry standards.
- Health insurance.
- Free onsite parking.
- 25 days annual leave (increasing in increments to 30 days after 6 years' service).
- Your birthday off work.
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