Manager, GRA, LRR Israel, Region Europe

Key activities & responsibilities

Strategy (execution) & management

• Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities; monitor and report progress consistently to stakeholders
• Ensure strict compliance with local regulations, actively participating in policy activities with industry groups and trade associations. Act as RA representative in audit/inspection and ensure readiness and timely CAPA closure in alignment with other functions
• Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulation and subsequently communicate requirements to GRA and local staff; participate actively in regulatory meetings, forums, and conferences to stay informed share insights and best practices within the organization

• Act as primary interface with local HAs, industry groups, and trade associations, representing the company's regulatory interests and fostering positive relationships; lead in-country regulatory processes, acting as the final contact point with HAs for licenses, partner regulatory licenses, and market access collaborations
• Prepare, organize and coordinate local specific documentation e.g. module 1 to meet national submission requirements and be responsible for keeping up-to-date local national systems as per local legislation
• Provide critical support for implementation of local legislation , promotional material review, interpretation of regulations and regulatory agency expectations as well as lead regulatory strategies for product launches and integrations at affiliate level
• Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs; monitor status of submitted regulatory activities with local health authorities
• Act as primary RA representative for local ComOps: adopt a business perspective, explore opportunities and translate this thinking into actionable plans that fit with strategy
• Keep RIMS up to date with local activity and ensure compliance KPIs are adequately kept on track
• Ensure compliant labeling (SmpC, PIL, packaging) and manage timely updates including translation, and promotional material review

• Relevant bachelor's degree or equivalent secondary education e.g. natural sciences (biology, chemistry with pharmacological focus)
• Advanced degree (Master's or PhD) preferred in e.g., law, legal affairs, natural sciences (biology, chemistry with pharmacological focus)
• (Optional but desired) Regulatory Affairs Certification specific to the region e.g., Regulatory Affairs Certification (RAC), Certified Regulatory Affairs Professional (CARP), Certified Professional in Healthcare Compliance (CHPC)

• 3-5+ years of (local) regulatory knowledge and experience in a regulatory authority facing role; i.e. comprehensive understanding of regional and global regulatory requirements, guidelines and processes
• Project management skills and leadership skills; i.e. proven experience in managing e.g., regulatory submissions, timelines and cross-functional teams to ensure timely and successful product registrations and compliance