Details:
- Location: RG2 Great Lea Common Wokingham
- Date: 2 weeks ago
Description:
Regulatory Life Cycle Manager Medicinal products
Reading & Remote
12 month contract (PAYE)
Our client is a multinational consumer goods corporation; specializing in a wide range of personal care and hygiene products; organized into several segments including Beauty; Grooming; Health Care; Fabric & Home Care; and Baby and Feminine care.
Role:
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.
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.
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 organization 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.
Person:
Professional with initial regulatory affairs experience (1-2 years), preferably in consumer health and preferably across multiple regulatory classification areas
Strong motivation for dossier maintenance and product change management
Skilled in working with complex Regulatory databases
Demonstrated ability to work independently in a matrix environment to build superior relationships with stakeholders
Organizational skills and solution-oriented attitude to handle a complex product-country portfolio