Senior Regulatory Affairs Manager

仕事内容

Job FamilyRegulatoryCityLa Tour-de-PeilzRegionVaudCountrySwitzerlandContract TypePosting Start Date02-Jul-2021Company OverviewGalderma, the world’s largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit Job DescriptionSenior Regulatory Affairs Manager covers all aspects of Regulatory Affairs for Galderma’s portfolio of Medical Devices (aesthetics products). The position is responsible for developing strategies for new product applications and worldwide regulatory submissions, ensuring implementation of regulatory requirements, assessing regulatory impact of labeling updates and when necessary - notifying authorities and ensuring regulatory guidance on the project and organizational level.The role will also provide coaching and mentoring to team members and Galderma’s employees to increase Regulatory Affairs awareness in the company.Job ResponsibilitiesProvides regulatory expertise in projects and line related activitiesCompiles overall regulatory strategy within projects, both for the new products and line extensions (including variations)Files and obtains marketing applications worldwideLicenses maintenance activitiesFiles clinical trial applications to authoritiesCoordinates compilation of new and updated labeling materialsCompiles, reviews, and approves documentation for regulatory purposesLeads and coordinates contact with regulatory bodies, affiliates, partners, consultants, and distributorsTracks regulatory status and plans within respective product responsibilityRepresents Global RA both internally and externallyPrepares and participates in audits internally and externallyMaintains up to date level of knowledge of regulatory guidelines for medical devicesMinimun RequirementsUniversity Degree within the Pharmaceutical field or equivalentMinimum 8 years of experience in Global Regulatory Affairs in the international Medical Devices companiesFluency in EnglishAbility to communicate and collaborate both internally and externally with colleagues, authorities, and affiliatesCapability to prepare coherent regulatory reports and filingsGreat attention to details with a thorough and methodical approach to workAbility to analyze information in a structured mannerWorks well under the pressure of a high workload, meets deadlines and responds on timeHigh sense of responsibility and accountability to ensure compliance and to inspire colleagues to do the sameIndependency and ability to take decisions to deliver results