Role responsibilities

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.

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