Non-Pharma Global Regulatory Affairs Specialist

Alfasigma; Milano; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A global healthcare company based in Italy seeks a Non-Pharma Global Regulatory Affairs Specialist to manage regulatory documentation for projects in compliance with EU regulations. The role involves collaboration with internal teams and contributes to regulatory strategies for new projects. Candidates should have at least 5 years of experience in Regulatory Affairs, preferably in food supplements, medical devices, and cosmetics. A competitive salary and professional growth opportunities are offered.

Servizi

Competitive salary

Comprehensive benefits

Opportunities for professional growth

Competenze

• At least 5 years' experience in Regulatory Affairs preferably in food supplements, medical devices, and cosmetics.
• Good knowledge of EU regulations for medical devices, food supplements, and cosmetics.
• Relevant certifications in Regulatory Affairs are a plus.

Mansioni

• Manage regulatory documentation for medium- and low-complexity projects.
• Contribute to regulatory input for new projects and support regulatory strategies.
• Collaborate with internal teams and external vendors for submission preparations.

Conoscenze

Regulatory Affairs

Attention to detail

Time management

Organizational skills

Communication skills

Team collaboration

Proficiency in Microsoft Office

Familiarity with document management systems

Fluency in English

Formazione

Advanced degree in Life Sciences, Pharmacy, Chemistry, or related field

Descrizione del lavoro

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 within internal systems.

Team and Cross‑functional Collaboration

• Coordinate with internal departments (e.g., Quality, Medical, Supply chain, Affiliates) to collect and verify documentation and regulatory inputs.
• Liaise with Global QA/Supply Chain/Global R&D for regulatory issues related to finished products/raw materials/supplier assessment.
• Engage with external vendors and consultants to support submission preparation and ensure delivery of expected outcomes.
• Provide timely updates on task progress and proactively flag issues to the Leader or Head.
• Support regulatory audits and inspection readiness activities for assigned products.

Learning Development

• Participate in on‑the‑job training to build familiarity with global regulatory frameworks and submission types.
• Take ownership of self‑development activities and integrate learnings into daily practice.

Process Improvement and Team Contribution

• Develop awareness of the evolving regulatory and compliance landscape and collaborate with internal teams to support adherence across regulatory activities for assigned tasks.
• Actively contribute to the generation and refinement of team tools, templates and processes by sharing feedback and improvement ideas based on execution experience.
• Support the maintenance and implementation of standard operating procedures and departmental guidelines in collaboration with peers and leaders.

Qualifications

• At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors.
• Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred.
• Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field.
• Relevant certifications in Regulatory Affairs are considered a plus.
• Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics.
• Strong attention to detail, time management and organizational skills.
• Willingness to learn and ability to work effectively in a team‑based environment.
• Strong communication and interpersonal skills.
• Proficiency in Microsoft Office Suite and familiarity with document management systems.
• Fluent in English, both written and spoken.

Why Join Alfasigma

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open‑mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward‑thinking team dedicated to shaping the future of the pharmaceutical industry.