Regulatory Affairs Manager
ProClinical is advertising a vacancy for a Regulatory Affairs Manager position with one of the largest workforce management solution companies in the world. This exciting organisation, which specialises in multiple scientific and engineering sectors, is seeking a driven and personable incumbent to join their team in Uxbridge. The company's prestigious status makes this the perfect opportunity for the applicant to utilise a hands-on approach in order to develop their career progression.
- Leading the compilation of CMC regulatory packages for submission and acting as the lead for a program under supervision.
- Collecting/creating country specific documents for regulatory filings worldwide.
- Compiling and maintaining CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead.
- Ensuring the compliance via timely submissions to regulatory agencies.
- Coordinating the collection of functional documents in support of regulatory applications.
- Interfacing with Regulatory Operations.
- Supporting execution of regulatory strategy.
- Supporting process improvement initiatives, standards development, and metrics.
- Assisting in template development and maintenance.
- Contributing to training and supervision of junior staff.
Skills and Requirements:
- Demonstrable experience within emerging markets.
- Fluency in English, in both a written and verbal capacity.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solving problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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