REGULATORY AFFAIRS PROJECT MANAGER

• 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);

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.