The GPS Global Regulatory Affairs Life Cycle Management Team based at my clients site in Reading has a 1-year position available to build Medicinal Product capability in and outside Europe.
We are looking to hire a candidate strongly interested in Regulatory Affairs - with experience in medicinal products. You will grow and maintain major portfolio in particular for the European region, you will coordinate changes to existing products/dossiers keeping them on the market.
You will act as the point contact for our local regulatory colleagues, who manage local market and authority interactions, as well as with other technical & non-technical functions like MPD, Product Supply,QA, Marketing and manufacturing sites
Key Responsibilities:
- Build medicinal capability within Regulatory Affairs Life Cycle Management and ensure medicinal aspects are well reflected in projects, work processes, and in our systems.
Business Use
- Enable PHC business for the relevant portfolio within and outside Europe region by delivering to time and to GPS SOPs on agreed and aligned priority base business projects across each franchise & region, as well as on "LCM initiatives" requiring changes to existing products/dossiers.
- Coordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe.
- Coordinate with Local Regulatory Affairs for variations, renewals and answering health authority requests.
- Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve variations for the specific product portfolio.
- Advise organisation of potential regulatory risks in normal day to day activities and recommend compliant actions.
- Ensure regulatory assessments are conducted for change controls in the respective Veeva Quality Tracking system.
- Ensure that the Veeva Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents.
- Provide strategic input into Regional Product labelling and approval to enable commercial activation of product launches.
- Connect and synergy with all stakeholders related to the responsible roles.
- Contribute to new regulatory policies, systems and processes to reinforce governance and compliance across LCM and the regulatory Affairs function.
Requirements:
Education: A minimum of a Masters' degree in pharmacy, engineering, chemistry with knowledge in Regulatory Affairs.
Languages: Proficiency in English.
Geography: Ability to work permanently in country of residence
Job Qualifications:
1.Professional with initial regulatory affairs experience (1-2 years), preferably in consumer health and preferably across multiple regulatory classification areas
2.Strong motivation for dossier maintenance and product change management
3.Skilled in working with complex Regulatory databases
4.Demonstrated ability to work independently in a matrix environment to build superior relationships with stakeholders
5.Strong initiative and follow-through with accountability for work quality
6.Organisational skills and solution-oriented attitude to handle a complex product-country portfolio
7.Excellent attention to detail, good communication and presentation skills
8.Results oriented and self-motivating with an ability to influence others
9.Openness to change and ability to think out of the box
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
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