Lavori attuali relativi a Non-Pharma Global Regulatory Affairs Specialist - Bologna - Alfasigma S.p.A.
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Bologna, Italia Alfasigma S.p.A. A tempo pienoA leading global healthcare company in Bologna is seeking a Non-Pharma Global Regulatory Affairs Specialist. This role involves managing regulatory documentation and supporting submissions for various projects across EU and other markets. The ideal candidate should have over 5 years of experience in Regulatory Affairs, preferably in food supplements or...
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Non-Pharma Global Regulatory Affairs Specialist
3 ore fa
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 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 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. Principal Accountabilities Regulatory Activities Contributing 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 meeting 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 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, 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 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. 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. Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field. Relevant certifications in Regulatory Affairs are considered a plus. Good knowledgeof 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. #J-18808-Ljbffr
