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Non-Pharma Global Regulatory Affairs Specialist Jobs

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Non-Pharma Global Regulatory Affairs Specialist
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Join our team in Bologna as a Global Regulatory Affairs Specialist for Non-Pharma products. You will manage EU and RoW submissions for food supplements, medical devices, and cosmetics. This role requires 5+ years of experience and offers competitive pay with strong growth opportunities. Apply to ...
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Italy , Bologna
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Not provided
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Alfasigma
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Until further notice
Explore a world of specialized career opportunities with Non-Pharma Global Regulatory Affairs Specialist jobs. This critical profession sits at the intersection of science, law, and global commerce, ensuring that non-pharmaceutical products—such as medical devices, dietary supplements, cosmetics, and consumer health goods—can be legally marketed and sold across international borders. Professionals in this field act as essential navigators, guiding products through the complex web of regional regulations to achieve and maintain market access. A Global Regulatory Affairs Specialist for non-pharma products typically manages the end-to-end regulatory lifecycle. Their core responsibility is to develop and execute regulatory strategies for new product launches and existing product maintenance. This involves preparing, compiling, and submitting technical dossiers, applications, and notifications to health authorities worldwide, including in the EU, North America, Asia, and other key markets. They are responsible for ensuring all product labeling, packaging, and promotional materials comply with local regulatory mandates. A significant part of the role is ongoing lifecycle management, which includes managing renewals, registrations, and handling regulatory changes that could impact product compliance. Specialists often serve as the central point of contact, liaising between internal cross-functional teams like Research & Development, Quality Assurance, and Supply Chain, as well as external bodies such as consultants, testing laboratories, and regulatory agencies. The day-to-day work demands a blend of scientific understanding and meticulous project management. Common tasks include maintaining regulatory databases and tracking systems, conducting regulatory impact assessments for product changes, and supporting regulatory audits or inspections. These professionals play a key supportive role in geo-expansion projects by researching new market requirements and coordinating the necessary documentation. They also contribute to internal process improvements, helping to refine templates and standard operating procedures. Typical skills and requirements for these jobs include a strong educational foundation, usually an advanced degree in Life Sciences, Chemistry, Engineering, or a related field. Several years of direct experience in regulatory affairs within relevant sectors is standard. Candidates must possess a solid working knowledge of major regulatory frameworks, such as the EU Medical Device Regulation (MDR), food supplement directives, and cosmetic regulations. Success hinges on exceptional attention to detail, superior organizational skills, and the ability to manage multiple complex projects under tight deadlines. Strong interpersonal and communication skills are vital for effective collaboration. Proficiency with standard office software and document management systems, along with fluency in English, is universally required, with additional languages being a significant asset. For those with a passion for global markets and a detail-oriented mindset, Non-Pharma Global Regulatory Affairs Specialist jobs offer a dynamic and impactful career path dedicated to bringing essential products to consumers everywhere.

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