Here is an exciting job opportunity to join a successful and innovative company in the health care industry who is looking to hire a Regulatory Director based in Cambridgeshire, UK. This role will be on a contract, part-time basis.
- Develop and lead regulatory strategies and initial registration plans for approval of specific products for Europe, Japan, China and Australia (US and Canada if required)
- Provide regulatory advice and expertise to R&D project teams and commercial counterparts.
- Provide regulatory expertise to optimise drug developments and initial drug registration and approval strategies on assigned projects:
- Provide up-to-date regulatory expertise on current drug development and marketing authorisations requirements and procedures to develop faster to market product development and approval strategies with optimal labelling.
- Advise drug development teams at the company, regulatory management as well as regulatory representatives at our independent associated companies (IACs) on the interpretation of emerging regulatory and scientific guidelines or regulatory processes and their impact on current product development plans.
- Develop and agree with Regulatory Leadership Team regulatory strategies for new products and new indications of existing products
- Together with the Head of Regulatory Strategy take part in interactions and negotiations regarding drug development plans (incorporating orphan drug designations and paediatric plans as appropriate), registration requirements, submissions and approvals of assigned projects.
- Ensure records of tasks and registered product information is maintained in the internal regulatory databases.
- Ensure the delivery of submissions (MA, orphan drug designation, scientific advice applications) in a timely manner
Qualifications, Skills and Experience:
- Science degree or equivalent qualified: e.g. chemical and physical sciences, pharmacy, biochemistry, medical chemistry, biomedical science; or HND or equivalent industry experience where appropriate with extensive regulatory/clinical experience working in research-based drug development role.
- Track record of overseeing a substantial number and quality of drug submissions and approvals working with or from within health authorities such as EMA, FDA, BfArM, MHRA, TGA, PMDA and others.
- Broad, in-depth knowledge and experience of drug development and approval requirements in multiple non-pain therapeutic areas.
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 Latifah Khan on +44 203 8234 367 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.