סקירה כללית
^^משרה זו נלקחה מ Career^^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 RA support and stakeholder engagement 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 Education 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) Skills and experience 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 Our Benefits We encourage you to make your well
• being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life
• saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL Do work that matters at CSL! CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here. CSL Global Privacy Notice for Job Applicants and Candidates
דרישות המשרה
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
