REGULATORY AFFAIRS PROJECT MANAGER

Arethusa Srl; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical company in Milan is seeking a Regulatory Project Manager with over 6 years of experience in the healthcare sector. Responsibilities include managing regulatory projects, collaborating with cross-functional teams, and maintaining product information compliance. The ideal candidate holds a relevant scientific degree and speaks fluent English. This role is essential for ensuring timely regulatory submissions and approvals.

Competenze

• 6+ years of experience in a pharmaceutical/healthcare company.
• Strong knowledge of pharmaceutical laws and regulations.
• Knowledge of fundamentals of medical devices.

Mansioni

• E2e management of regulatory projects for timely submission and approval.
• Act as the first point of contact for multiple stakeholders.
• Update local product information with global labeling teams.

Conoscenze

Regulatory project management

Pharmaceutical laws and regulations

Life cycle management

Team collaboration

Problem-solving

Fluency in English

Formazione

Scientific Degree (Pharmacy, Pharmaceutical chemistry, Chemistry or related disciplines)

Descrizione del lavoro

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.