Bologna, IT
Non-Pharma Global Regulatory Affairs Specialist
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 doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and 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 and expand our reach across diverse markets.
As we continue to grow, we are seeking a Regulatory Affairs (RA) Non-Pharma Specialist to join our team!
Scope of the role
The Global Regulatory Non-Pharma Specialist manages regulatory documentation and operational activities for medical devices, food supplements, and cosmetics across EU and Rest of World markets.
This role supports timely regulatory submissions, lifecycle management, and cross-functional collaboration while developing expertise in non-pharma regulatory frameworks under the guidance of experienced colleagues.
Your role
Regulatory Activities:
- Contribute to cross-functional teams providing regulatory input for new projects, products, and processes
- Prepare and submit regulatory documentation for marketing authorizations, geo-expansions, variations, renewals, and post-marketing activities
- Collaborate with R&D to integrate regulatory requirements during product design and development
- Coordinate with local affiliates and global stakeholders to align submissions with timelines and business priorities
- Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations
- Support regulatory strategies through impact assessments and risk identification
Compliance and Documentation Management:
- Maintain regulatory tracking systems, databases, and document repositories with accurate information
- Support systematic maintenance of product and country regulatory databases ensuring data consistency
- Contribute to geo-expansion activities by organizing and uploading regulatory information across markets
- Manage content and data in company systems
Team and Cross-functional Collaboration:
- Coordinate with internal departments (Quality, Medical, Supply Chain, Affiliates) to collect and verify documentation
- Liaise with Global QA, Supply Chain, and R&D on regulatory issues related to finished products and raw materials
- Engage with external vendors and consultants to support submission preparation
- Support regulatory audits and inspection readiness activities
Process Improvement
- Contribute to the generation and refinement of team tools, templates, and processes
- Support maintenance and implementation of standard operating procedures
- Participate in on-the-job training to build familiarity with global regulatory frameworks
Who are you
- At least 5 years in Regulatory Affairs, preferably within food supplements, medical devices, and cosmetics sectors. Exposure to EU and/or Rest of World regulatory operations is preferred
- Advanced degree in Life Sciences, Pharmacy, Chemistry, or related field. Relevant certifications in Regulatory Affairs are a plus
- Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
- Strong attention to detail, excellent time management and organizational abilities, effective communication and interpersonal skills
- Proficiency in Microsoft Office Suite and familiarity with document management systems
- Fluent in English, both written and spoken
- Willingness to learn, ability to work effectively in team-based environments, proactive in flagging issues and providing updates
What's in it for you
- Opportunity to work on diverse projects across medical devices, food supplements, and cosmetics in global markets
- Structured learning and development path with guidance from experienced regulatory professionals
- Hands-on experience in regulatory submissions, lifecycle management, and cross-functional collaboration
- Exposure to EU and international regulatory frameworks
- Contribution to innovative healthcare products that improve quality of life for patients and consumers worldwide
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.