Job Purpose

The International Regulatory Affairs Project Manager is responsible for collaborating with European and global Health Authorities to secure new product registrations and ensure the ongoing maintenance of existing marketing authorizations. This role acts as a critical link between the company, its subsidiaries, and international partners to ensure compliance with global regulatory standards, particularly within the rare disease and niche market sectors

Key Responsibilities

Regulatory Strategy & Dossier Management

• Lead the preparation, submission, and strategic follow-up of all regulatory filings, including pre-authorization dossiers (ODDs, IMPD, IND, PIP, NDA, MAA) and post-authorization lifecycle management (variations, renewals, annual reports, and re-assessments).
• Provide high-level scientific documentation and regulatory support to international subsidiaries and external partners.
• Monitor and interpret international legislation to ensure the company's portfolio remains compliant with evolving global standards.

Operational Execution & Compliance

• Oversee and track the progress of all global filings, ensuring timely responses to queries from Health Authorities.
• Review and approve mock-ups for labeling and final packaging in coordination with the production department and partners.
• Manage and supervise regulatory work outsourced to Contract Research Organizations (CROs) and external experts.

Communication & Stakeholder Management

• Act as a primary point of contact for internal departments, global subsidiaries, and external stakeholders (Health Authorities, Manufacturers, and Professional Bodies like LEEM, AFAR, DIA).
• Facilitate internal knowledge sharing regarding regulatory issues to maintain a high level of expertise across the team.
• Represent the company at external meetings and provide detailed reporting to senior management.

Required Education

University Degree in Pharmacy (Pharmacist) or a related Scientific field.

Required Skills and Experience

• 4 to 5 years of experience in the Pharmaceutical Industry, with a proven track record specifically in Regulatory Affairs.
• Prior experience in the Rare Disease field or Niche Markets is highly preferred.
• Proven experience in handling both pre-approval (IND/IMPD) and post-approval (variations/renewals) dossiers.
• Strong ability to draft, review, and edit complex scientific and regulatory submission files.

Required Behaviours and Competencies

• Ability to build strong relationships in a multi-cultural environment and communicate effectively with diverse stakeholders.
• A flexible and proactive "hands-on" approach to identifying issues and implementing effective solutions.
• Strong capacity to prioritize tasks, manage deadlines, and maintain financial awareness of project scopes.
• A natural team player who promotes a good level of understanding and interest in regulatory issues among colleagues.
• Ability to act with autonomy while keeping management and partners appropriately informed.

Required Languages

Native or professional fluency in English (written and spoken).

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.