Regulatory Affairs Specialist
- Experience Level
- Experienced (non-manager)
A leading pharmaceutical company is seeking for a Regulatory Affairs Specialist to join their team in London for a 9 month contract period. The organisation focuses on selected emerging markets in the Middle East, Africa, CIS Region, and Latin America and advancing drug delivery technologies specialising in modified released oral and oral dispersible forms. The Specialist will join this company in their office in Zurich.
- Supporting of regulatory managers in all administrative aspects.
- Regularly tracking and documenting of Product Information updates (EU & CH) in Health Authority portals according to company processes.
- Organising the maintenance of printed packaging materials (EU & CH).
- Providing timely Regulatory Intelligence updates (EU&CH) to the RA team members.
- Being responsible for the RA contract database.
- Uploading documents and dossiers into Document Management System (Docubridge).
- Supporting regulatory managers in terms of preparation of new marketing authorization applications and variations (e.g. preparation of Module 1, compilation of application forms).
- Uploading of dossiers via electronic portals (to Health Authorities).
- Assuming responsibility for the electronic RA solutions (DMS, eSub tool, RIMS)
- Support the dispatch of dossiers to third party (customers, partners, distributors, etc.)
Skills and Requirements:
- Life science degree or equivalent
- Experience in a pharmaceutical industry especially in regulatory affairs with focus on eCTD & Product Information
- Excellent planning and organizational skills with capability to prioritize tasks and adhere to timelines
- Excellent computer skills - eCTD / Document Management Systems (experience with docuBridge is an advantage)
- 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 with computer skills, such as 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 Joe Beddows at +44 203 854 2623 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.