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Personal Health Care Scientist - Regulatory affairs (m/f)
Have you ever wondered how is it like to handle Regulatory services in an international company with an impact on billions of consumers?
Your responsibilities would be to manage Regulatory activities (RA) to obtain and maintain Marketing Authorizations (MAs) for medicinal products and/or other Authorizations for non-medicinal products (e.g. medical devices, food supplements, cosmetics etc) in full compliance with national and European regulations and technical standards as well as internal Corporate Standard Operating Procedures and Processes.
You will apply your technical expertise on scientific and medical activities to ensure full compliance of advertising and promotional materials to relevant regulations and guidelines and to help drive business via consumers and Healthcare Professionals.
You will contribute to develop and implement scientific dissemination plans consistent with brand strategies.
In particular you will:
1. Support Portfolio in the assessment of new ideas.
2. Prepare the regulatory strategy for product registration with the support of the Central RA team.
3. Manage all product (Medicines and non – medicines) life cycle, including variations, renewals and other local requirements (ex. Sunset clause if applicable).
4. Manage via Corporate systems all the activities needed to ensure full compliance of labeling and artworks, according to local/European requirements and Company standards.
5. Revision and clearance via Corporate systems of advertising materials to ensure full compliance with local/European regulatory requirements, internal data, documentation and processes.
6. Prepare and submit all Pricing applications.
7. Interact with Ministry of Health and other Regulatory Authorities for above activities creating and fostering a network of contact to facilitate dialogue during regulatory procedure.
8. Ensure full compliance to national/ European regulations, Company standards and SOPs of all marketed products.
9. Accurate maintenance of Corporate System and Databases for products information, data and documentation.
10. Management of any external database required for maintenance of medicinal and non-medicinal products (e.g. MoH databases).
11. Keeping up to date on and interpreting national and international RA legislation and regulations.
12. Participate in RA related meetings and execute action points
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