RIF. 3687: REGULATORY AFFAIRS PROJECT MANAGER
Our client is a Multinational Consumer Health Company
Role responsabilities:
- E2e management of regulatory projects, ensuring timely submission and successful approval.
- Taking part of cross functional projects, being the LOC Regulatory first point of contact for QSC, CMC, CMO and internal manufacturing site.
- Management of local product information update in accordance with GDS, being the LOC Regulatory first point of contact with global labelling team.
- Medicinal product upgrades management – eg. new indication, switch RX to OTC, improved formulation, new claims.
Qualifications & Skills
- Relevant previous experience (6years +) in a pharmaceutical/healthcare company;
- Strong knowledge of pharmaceutical, laws and regulation and fluent management of the life cycle management;
- Knowledge of the fundamentals of medical devices;
- Scientific Degree (Pharmacy, Pharmaceutical chemistry, Chemistry or related disciplines);
- Fluent in English.
Preferred
- Good team player, with strong interpersonal skills to work well in cross-functional teams;
- Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods;
- Results-driven mindset and problem-solving skills;
- Ability to work in a fast-paced, dynamic environment, managing multiple priorities.