Summary
About the Role
Key Accountabilities:
- You will oversee and manage business processes and their links to systems, and own certain business processes within the assigned business process area.
- Drive and coordinate with business process owners, the end-to-end process strategy within respective area to ensure alignment within and outside RA.
- Drive and implement continuous process improvement strategies or closure of process gaps across process area. Point of contact for other functions outside RA for process alignment and new process implementation within respective area.
- Support quality and consistency of RA regulatory compliance activities in assigned region through implementation of new processes, policies, metrics and appropriate training, and ensuring data compliance in the global RIM system.
- Partner with Region Head, Sub-region Heads, and Subject Matter Experts from assigned region to implement and track training for policies, processes and procedures.
- Participate in cross-functional process improvement projects to represent the function; help to identifying resources from the function to support cross-functional projects
- Support the preparation of the RA organization for internal global audits including CAPA management, collaborating with QA to prepare RA/ Country Organisations for external inspections at HQ including CAPA management.
- Work with Director RA Process Excellence to address potential quality issues and emerging compliance concerns and recommend solutions, providing backup support, as needed
Your experience:
- Life science degree.
- Pharmaceutical industry experience, in Regulatory Affairs.
- Demonstrable experience in working knowledge of SOPs and compliance.
- Good interpersonal, negotiations and communcation skills.
- Experience working in complex global environments and cross functional teams
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?:https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
