Regulatory Affairs Officer

map_markerSlough CoinNegotiable

Vacancy summary

Vacancy summary

Reference: 01566

Job Type: Temporary

Date Posted: 10 August 2016

Working within a global organization, you will be taking on the responsibilities of drafting and implementing the regulatory strategy for a number of keys projects pertaining to commercialisation in the Europe/Intercontinental region. Coordinating the preparation and submission of documentation, supervising the critical and constructive review of regulatory dossiers, and defining the content of those dossiers, you will be managing the European marketing authorization procedures and ensure that all regulatory bodies have been consulted and kept abreast of the development of these projects. Liaising with manufacturers, regulatory bodies, and internal departments you will be taking on the responsibility of ensuring that the projects remain within compliance at all times. This role is available for immediate start and will last approximately 6 months. Key responsibilities will include: • Reporting to individual regulatory bodies and internal functions • Providing consistency throughout the projects between local registration plans and manufacturing plans • Drafting and implementation of the regulatory strategy • Reviews of regulatory dossiers and defining the content of regulatory submissions You will have demonstrable experience within the regulatory department of a pharmaceutical business. With a first class knowledge of regulatory procedures and the ability to keep projects compliant. You will need to have an academic qualification in a life sciences subject (or equivalent experience) in order to be successful with your application. You will be joining a business whose key focus has been the development of innovative solutions to disabling conditions. Improving the quality of life and life expectancy is priority one within this business and as such they look for innovative thinkers and strategy-builders to come in to their team. Due to time constraints, only successful applicants will be contacted for this specific vacancy. Please apply via this website to be considered for this role. Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Business in relation to this role.

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