In view of our continued global growth and increase of production capacities, we are expanding our regulatory team. For this reason we are looking for further support and recruiting our new RA International Team Lead at our biotech production site in Meyrin/Geneva. In this position you take care of overseeing regulatory activities (new registrations and maintenance) in Eurasia, APAC, MEA and LATAM regions and managing the International regulatory team.
Your main missions are as follows:
• Define and implement regulatory strategy for the International region (Eurasia, APAC, MEA and LATAM) in liaison with other regulatory teams. Timely plan and follow activities for the maintenance of existing marketing authorizations and obtaining new marketing authorizations.
• Good knowledge & appropriate interpretation of guidelines, directives etc. Interpret consequences of changes in the legislation and communicate them appropriately.
• Improve regulatory workflows and processes.
• Financial planning, organization and accountability for project and resource related budget
• Act as business partner for the commercial organization. Improve business performance by shortening time to market and speed of product change implementation.
• Represent the International Regulatory Affairs Team in relevant committees and projects teams internally and externally.
• Interact with Regulatory authorities, affiliates and partners.
• Liaise with local partners (distributors) and develop good regulatory practices.
• Prepare and coordinate meetings with Health Authorities
• Provide organizational, technical and disciplinary leadership.
• Responsibility for the target-oriented implementation of tasks within the Regulatory Affairs International team with optimal application of the available resources
• Development and empowerment of team members. Carrying out individual performance and development reviews. Definition of objectives and training measures. Carrying out of training measures with adherence to internal procedures (guidelines, SOPs, rulings, etc).
• Supervision of the group-specific tasks within the framework of assuring regulatory compliance, administration of regulatory dossiers and guaranteeing the tracking of regulatory history.
To carry out these tasks the ideal candidate will have a Scientific or Medical degree in addition to the following:
• More than 10 years’ work experience in Regulatory Affairs in International markets
• Experience in meetings with Has and management of local partners (distributors)
• People management
• Leadership competencies such as product management and diplomacy skills
• Negotiation skills
• Ability to manage different cross-functional stakeholders
• Apply a client-centric mindset and focus on business opportunities
• Good command of English and French
• Intercultural competence