Regulatory Project Manager
ProClinical is working with a global speciality pharmaceutical company that is seeking a Regulatory Project Manager to be based in London on a contract basis. This role will be project managing and providing regulatory support to assigned tasks and ensuring compliance with international regulatory requirements is maintained whilst delivering on the company strategy.
- Provide regulatory guidance and advice for assigned projects/tasks.
- Due diligence on new product launches
- New market entry assessments (Europe and Asia)
- System design and set up (eCTD)
- Dossier update
- Provide regulatory strategy/ies to ensure a timely route to market
- Proactively contribute to project teams as and when required, e.g. manufacturing site transfers
- Performs regulatory assessments including; gap analyses, risk planning and mitigation
- Solid, broad regulatory experience and expertise including EU and/or ROW.
Skills and Requirements:
- Demonstrated experience in planning and project management to achieve targeted goals.
- Strong verbal and written communication skills.
- Good interpersonal skills and problem-solving capabilities.
- Ability to work on multi-projects and to maintain high standards.
- Ability to work effectively across a matrix organization.
- Ability to work independently and prioritize with minimal instruction.
- Ability to think strategically.
- Degree in Biology or Chemistry related-disciplines preferred.
- 5+ years of Pharmaceutical industry experience (pharma/service provider).
- 5+ years of EU/ROW/global regulatory experience
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 call Peter Duvall on +44 203 0789 542 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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