Our client, a leading pharmaceutical company, is searching for a Regulatory Associate Director to work on a part-time basis in Cambridge, UK.
Job Role and Responsibilities:
- 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.
- Contribute to the development of people and foster the company's core values through mentoring, coaching and acting as a role model for all staff in regulatory affairs
- 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 company product development plans.
- 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 the delivery of submissions (MA, orphan drug designation, scientific advice applications) in a timely manner
- Ensure, where appropriate, that the electronic document management system is used for all submission documents
- Ensure regulatory strategy plans are in place and kept up to date for all assigned product and that they are optimised in respect of regulatory approvals, pricing & access
- Manage CRO and partner relationships where development regulatory support is needed
- Where requested represent the regulatory affairs department at pharmaceutical research trade associations and other networked representations. Use knowledge in regulatory affairs and standing in the regulatory community to influence widely the company's ability to undertake drug development and product registrations
Education, 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.
- A strong strategic regulatory mindset and demonstrated ability in representing the company to various regulatory health authorities in both diplomatic and persuasive ways.
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.