Endereço
Forma de trabalho Work Model: Hybrid
Locality: São Paulo
About the Role:
1,800+ associates. 85+ countries. 1 goal. At Novartis, we are dedicated to discovering and developing new treatments for diseases including cancer, heart disease, and neurological conditions—and delivering them at a scale to reach as many patients as possible. Novartis has a unique and promising portfolio with approximately 70 projects as potential NMEs in development, 52 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. And you could be at the center of it all in Regulatory Affairs (RA), where your voice, experience, and quality mindset can truly make a difference in drug development at Novartis. Read on to learn about the role available in RA. We hope you will consider joining our global RA family.
As the Regulatory Affair Head Brazil you will be responsible to design the strategic vision for the Regulatory Affairs department in Brazil, and to ensure its successful execution in line with company’s objectives. You will lead the local regulatory team, ensuring development and registration milestones are met, and ensuring functional excellence including regulatory compliance. You will be responsible to develop registration strategies including lifecycle management and to translate regulations and guidelines into tangible regulatory strategies. In collaboration with the local leadership team and the regional regulatory organization, you will drive a collaborative enterprise thinking and implement the overall global regulatory strategy.
This role will work directly with the area: IM: CCSO - Medical Affairs
Key responsibilities:
• Sets up product development and strategic registration objectives in alignment with RA regional teams, RA global teams, commercial team objectives and in close partnership with the local Leadership Teams;
• Accountable for setting optimal regulatory strategy and driving the execution of the strategy, providing optimal use OF REGULATORY strategic opportunities to ensure acceleration of priority products during filing and registration, product advocacy activities, etc.;
• Directs the team for timely, optimal and quality submission OF REGULATORY documentation to the Health Authorities for the registration of new products/line extensions to support new launches, as well as for the maintenance of approved products to guarantee continued supply and appropriate, updated safety communications/label information. Drive negotiations with Health Authority to ensure best possible product labelling;
• Accountable for the implementation of compliance activities and associated processes for the entire Novartis portfolio. Provide strategic guidance and drive/support the local RA team and collaborates cross-functionally with relevant functions to ensure coordination and clarity in roles & responsibilities;
• Establishes and maintains strong relationships with key HA decision makers based on trust, in partnership with internal Novartis advocacy/policy groups and takes a leadership role to develop and support collaboration with industry associations and other forums;
• Assesses, in alignment with RA Region Head, appropriate level of RA resources in country and drives effective hiring, functional development and training of associates in line with Regional and Global RA vision;
• Responsible for activities related to people management and RA country budget.
