Manager, GRA, LRR Israel, Region Europe

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

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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

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