Job Reference: J5631848
Updated On: 13/08/2019
Status: Open to Applications
Back to results
Role OverviewWe are currently looking for a Regulatory Affairs Manager with experience of Clinical Trial Applications to join a leading Regulatory Consultancy based in the Hertfordshire area. As the Regulatory Affairs Manager - Clinical Trial Applications you will manage a small team focused on providing support for Clinical Trial Applications and amendments during studies conducted in the UK and Ireland.
Key Duties and ResponsibilitiesYour 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
Role RequirementsTo 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
Other jobs with similar skills
Regulatory Affairs Manager
London, Greater London | Experience Dependant
Hyper Recruitment Solutions are currently looking for a Regulatory Affairs Manager to join a leading Biopharmaceutical consultancy company based in the Greater London area. As the Regulatory Affairs M...Science
View & Apply
Regulatory CMC Manager
Hertfordshire | Experience Dependant
We are currently looking for a Regulatory CMC Manager to join a leading Regulatory Consultancy based in the Hertfordshire area. As the Regulatory CMC Manager you will offer internal and external cli...Science
View & Apply