Non-Pharma Global Regulatory Affairs Manager

• Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
• Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
• Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
• Provide and review regulatory assessments for change controls and product updates
• Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
• Provide critical review of documentation supporting regulatory applications
• Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
• Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
• Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
• Support other relevant assignments as directed by supervisor
• Person Responsible for Regulatory Compliance MDR, Art. 15 (b), (c), (d), (e) if applicable
• Manages content and data in Company system
• Ensure that all regulatory submissions are developed and maintained according to current SOPs, quality standards and applicable regulatory requirements
• Maintain accuracy of records in regulatory systems and document management platforms
• Liaise with Global Pharmacovigilance for safety issues
• 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 regulatory and strategic input during due diligence processes, assessments, and business development, licensing and partnership opportunities related to legacy assets
• Contribute to audits, inspections and regulatory authority communications for assigned products
• Act as a tutor for junior team members, providing guidance, feedback and support
• Take ownership of self-development activities and integrate learnings into daily practice
• Take part in continuous improvement initiatives and cross-functional projects
• Participate in training activities to build regulatory and project management capabilities
• Work with the team to improve processes, templates and tools used in regulatory project execution
• Champion understanding of the evolving regulatory and compliance landscape and collaborate with internal teams to ensure adherence across all regulatory initiatives for assigned topics

• Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
• Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
• Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
• Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
• Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
• Strong organizational skills, attention to detail, and ability to manage priorities
• Collaborative mindset and effective communication with team members and stakeholders
• Ability to operate independently on clearly defined assignments
• Proficiency in Microsoft Office Suite and regulatory submission/document management tools
• Fluent in English, both written and spoken

Relevant certifications in Regulatory Affairs are considered a plus

• Competitive salary
• Comprehensive benefits
• Extensive opportunities for professional growth and development