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International Regulatory Affairs Project Manager

ID:  2429
Date of Posting:  Apr 2, 2026
Business Area:  Regulatory Affairs
Job Type:  Direct Employee
On site / Remote / Hybrid:  Hybrid
Hub Office: 

Milano, IT

Territory: 
Full-Time or Part-Time:  Full Time
Seniority:  Mid-senior

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

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.

Apply now »