Non-Pharma Global Regulatory Affairs Specialist Job at Alfasigma (Bologna)

Job Description

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 colleagues 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.

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
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
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 meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
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
Manages 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
Contribute to geo-expansion activities by collecting, organizing and uploading regulatory information across markets
Coordinate with internal departments 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
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
Develops awareness of the evolving regulatory and compliance landscape and collaborates with internal teams to support adherence across regulatory activities for assigned tasks
Actively contributes to the generation and refinement of team tools, templates and processes by sharing feedback and improvement ideas based on execution experience
Supports the maintenance and implementation of standard operating procedures and departmental guidelines in collaboration with peers and leaders

Requirements

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
Advance 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

Nice to have

Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Relevant certifications in Regulatory Affairs are considered a plus

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

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Non-Pharma Global Regulatory Affairs Specialist

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