Regulatory Affairs Manager
Aa global biopharmaceutical company is advertising a vacancy for a Regulatory Affairs Manager position in their office in Cambridge. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.
- Supporting Head of Regulatory in delivering regulatory strategy, aligned to the overall development project objectives.
- Overseeing the regulatory CRO team to ensure timely and high-quality delivery of regulatory dossiers in emerging markets such as Brazil, Switzerland, Canada, and Taiwan.
- Serving as point of contact between regulatory CRO team and internal regulatory affair team for regulatory submission and defence activities for above mentioned regions.
- Overseeing the tracking of study objectives, issue resolution, and QC of CRO/vendor output.
- Reviewing regulatory documents.
- Interfacing with Project Team members, including Clinical Operations, Medical, Clinical Supplies, Drug Safety, Pharmacovigilance, and others as appropriate, to ensure that the Project Team is provided with all required regulatory functional advice and support.
Skills and Requirements:
- Bachelor degree or equivalent.
- Demonstrable expertise and experience in related areas.
- Able to communicate with other culture groups, proven teamwork, and collaboration skills.
- Willingness to travel nationally and internationally.
- 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 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.
€0.00 - €40000.00 per annum
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