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Non-Pharma Global Regulatory Affairs Specialist

Alfasigma

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Location:
Italy, Bologna

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

Not provided

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

Additional Information:

Job Posted:
December 17, 2025

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