Regulatory Affairs Process Manager

Key Responsibilities:

For assigned processes:

• Drive Business process creation, review by Process Review Committee (or equivalent), continuous improvement (including system, technology and automation needs to improve process performance). This includes developing, authoring/writing (as applicable) and maintaining procedural documents, establishing KPI and working with Training & Capability team members to provide associated functional training.
• Actively shepherd the process documents through the preparation process, self-author/write or provide guidance to author(s) on the content of a procedural document with respect to the process.
• In partnership with International / Regions and Policy, monitor and review emerging regulations and regulatory guidelines and analyze impact on Novartis regulatory processes
• Contribute to inspections and internal audits as applicable.
• Provide direct input and expertise in the areas of process design, risk management, governance, organizational design and compliance.
• Pressure-tested and risk-mitigate plans for transition from old to new/revised processes
• Ensure high level of connectivity, alignment, transparency and collaboration with Subject Matter Experts (SME) across RA and with other Development and corporate functions and departments, as required.
• In partnership with Systems team, incorporate technology portfolio deliverables into integrated transformation roadmap as well as any other non-drug development projects that have bearing on the broader transformation.
• Contribute to learning/training strategy for regulatory capability building, functional learning and learning technology.

Document Control Mastery:  Ensure meticulous version control and accessibility of quality documents (eg. SOP, WP, BPG), adhering to industry standards.

SOP operational management: Example: (opening and completing the Change request in relevant system, sending draft SOP for QMS review, getting the SOP uploaded in eSOPS, etc). to 'shepherd' the procedure through the procedure creation/update process.

Essential Requirements:

• Life Science Degree or other University degree with equivalent experience
• Regulatory and drug development experience
• Strong knowledge on E2E process, supporting system, regulations and business change(s).
• Strong working knowledge of QMS, SOPs and compliance
• Strong process authoring/writing capabilities
• Technology-savvy – ability to leverage and use systems, technology and automation (including digital assistants and AI tools) to derive efficiency in processes
• Ability to anticipate the impact of any change(s) from external and internal sources to the E2E process, to supporting systems and training
• Ability to effectively contribute to teams in a matrix environment
• Analytic, influencing, and communication skills.
• Ability to define metrics
• Process simplification and optimization

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.

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