Soho Flordis International Switzerland SA, located in Bioggio (Lugano), part of SFI Group, a global premium natural healthcare company with a rich history of over 200 years which operates in the high-quality natural health sector, comprising pharmaceutical products and supplements made using natural substances and extracts, is looking for a Global Product Regulatory and Science Manager in the Regulatory Affairs Department.
Key Responsibilities & Accountabilities:
• Execute and maintain regulatory strategies (including appropriate classification per country) for key product submissions in order to obtain/maintain regulatory authority approvals in line with business plans.
• Manage the global registration project including co-ordinating inputs, meeting milestones, identifying risks to timing and mitigating strategies, and communicating with regional regulatory, global and regional/local sales and marketing regarding status.
• Address deficiencies in product dossiers and implement strategy (involving problem solving and collaboration) to resolve any identified deficiencies within requested timelines.
• Ensure compliance of promotional material and labelling to appropriate regulations and legislations.
• Keep up-to-date with government legislation as it relates to regulatory/scientific affairs, with appropriate communication.
• Implement appropriate regulatory change control processes when necessary.
• Contribute to global product planning / launch teams to ensure timely product introduction.
• Provide regulatory support and recommendations for the assessment and licensing of new products/candidates and specified Research and Development activities that are endorsed by Marketing
• Support R&D in writing / updating CTD dossier or technical reports
• Managing data and documentation to provide a data package or dossier compliant to requirements of regional regulatory authorities, in collaboration with relevant Regional regulatory coordinators/managers.
• Liaise with external agencies, suppliers or others to ensure compliant submission dossiers and facilitate evaluation
• Strong commercial focus and ability to solve regulatory challenges in commercial situations
• Good strategic thinker and project manager who is outcome focussed
• University science degree
• Understanding of natural medicines, food supplements and/or pharmaceutical medicines
• 5 years + of Regulatory Affairs experience in natural medicines and dietary supplements
• Relevant experience in regulatory affairs together with knowledge of specifically clinically proven natural medicines
• Experience in R&D is desirable
• Proven track record in relevant areas of medical and pharmaceutical regulatory affairs
Contratto di lavoro: Tempo pieno, Tempo indeterminato
Who to Contact: firstname.lastname@example.org