This is an excellent opportunity to work for a global leader in the life sciences industry. The company is currently looking for a Regional Strategist to work specifically with vaccines in Surrey.
- Accountable for ensuring regional (EM) contribution to Global Regulatory Strategies and implementation plans for assigned projects.
- Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities.
- Partners with project teams and other customer groups to ensure required regulatory contributions meet business needs and are provided to the project teams, to agreed time and quality standards
- Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management and any risks mitigates
- Ensures an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the regional business are championed and communicated.
- Engages in appropriate activities in order to influence the regional regulatory environment through WRS-In Country colleagues, Agency contacts and/or Trade Associations as appropriate.
- Ensures business compliance and implementation of and adherence to Regulatory standards.
- Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.
Skills and Requirements
- Scientific Degree. A higher degree may be an advantage but is not essential.
- At least 5 years global regulatory experience in the pharmaceutical sector, Vaccines/Biologics experience beneficial.
- Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process particularly clinical trials experience at least in one country.
- Proven ability in developing and implementing regulatory strategy
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 on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
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