Regulatory Affairs Manager Clinical Trials
- Experience Level
- Full-time permanent position
- Office based in Essex
- Competitive package
- Management of project work/project lead for assigned Client(s).
- Preparation and/or coordination of CTAs and/or substantial amendments.
- Responsibility for maintaining standards including (but not limited to) QC of CTA team’s work. Maintenance of working processes and CT Management Plan.
- Maintaining an awareness of the EU Regulatory landscape and changing regulatory requirements. Assist in the development and training of junior employees, as required.
- Preparation and project management of CTAs.
- Preparation and/or review of CT application forms (including IRAS Forms), ARSAC submissions.
Full job description available on application
- 5+ years clinical trials experience (less for senior associate level).
- Strong understanding of the EU regulatory environment including guidelines.
- In depth knowledge of all CT application types.
- Ability to work under pressure and achieve timely submission and regulatory approvals
- Client will consider candidates from Senior Reg Affairs Associate CTA level upwards.
- Only candidates with existing right to work in the UK/EU will be considered
Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email firstname.lastname@example.org
To view our other vacancies, please visit our website on www.apexrecruitment.com
Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.
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