Non-Pharma Global Regulatory Affairs Specialist

Non-Pharma Global Regulatory Affairs Specialist
Join to apply for the  Non-Pharma Global Regulatory Affairs Specialist  role at  Alfasigma

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubling our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, entered rare and specialty segments, and strengthened both our pipeline and our people’s capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma’s history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide while expanding our reach across diverse markets.

As we continue to grow, we are seeking a RA Non-Pharma Specialist to join our team!

Scope of the role
The Global Regulatory Non-Pharma Specialist manages regulatory documentation and operational activities primarily related to medium- and low-complexity projects across EU and Rest of World markets.

This role contributes to the execution of timely regulatory submissions and lifecycle management tasks for the assigned projects in compliance with internal procedures and regulatory requirements.

The Specialist plays a valuable supporting role by aligning closely with team goals and contributing to high-quality execution.

The role operates under the guidance of a more experienced colleague in order to progressively increase in responsibility and complexity, allowing the development of experience, regulatory capabilities and functional competencies through hands‑on contributions and learning-by‑doing.

Principal Accountabilities
Regulatory Activities

Contribute in a cross‑functional team to provide the necessary regulatory input for the development of new projects (new internal processes, products, etc.).

Support regulatory strategies by providing impact assessments.

Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products.

Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned, including new marketing authorizations, geo‑expansions, variations, renewals and post‑marketing activities.

Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities.

Manage multiple tasks in a fast‑paced environment while keeping on task and to the company’s quality standards.

Contribute to the preparation of regulatory project updates in internal meetings and governance committee providing regulatory input and flagging risks.

Assist colleagues with administrative tasks (eg, meeting minutes).

Execute defined regulatory tasks within scope and deadlines under the guidance of the Head.

Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches.

Support other relevant assignments as directed by supervisor.

Compliance and Documentation Management

Manage content and data in company system.

Maintain regulatory tracking systems, databases and document repositories with accurate and up‑to‑date information.

Perform routine updates in regulatory databases to ensure accuracy and completeness.

Support the coordination and systematic maintenance of product and country regulatory databases, ensuring the accurate entry and updating of key information (product attributes, notification status, formula codes, artworks, English master texts and related data).

Contribute to geo‑expansion activities by collecting, organizing and uploading regulatory information across markets, supporting data consistency and traceability…