KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Manager - CTA will be varied however the key duties and responsibilities are as follows:
1. Line manage a small team of consultants and assist with the development and training of Junior employees.
2. Act as Project lead for assigned clients and coordinate the preparation of Clinical Trial Applications (CTAs) and substantial amendments.
3. Prepare, review and coordinate CTAs, ARSAC submissions and responses to questions.
4. Maintain internal standards and processes including Clinical Trail Management Plans
To be successful in your application to this exciting opportunity as the Regulatory Affairs Manager - CTA we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Clinical Studies etc.) in addition to hands on experience of the writing and submission of Clinical Trial Applications.
2. Proven industry experience of working in a Regulatory environment with a focus on Clinical Trials
3. A working knowledge of EU regulations for clinical trials exposure to submissions and regulatory approvals.
Key Words: Regulatory Affairs | Clinical Trails | Clinical Trial Application | CTA | Submissions | Substantial Amendments | EU Regulations | IRAS Forms | ARSAC submissions
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
- Regulatory Affairs
- Line Management
- Clinical Trial Applications
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