Regulatory Affairs Process Director

Job Description

Key Responsibilities:

- Under the supervision of the Process Transformation Lead, contribute to E2E regulatory processes transformation roadmap and implementation strategy for assigned processes and/or process area, further enabling increasing efficiency, reducing complexity and securing high quality or regulatory deliverables.
- Act as a core member of the RA Process Review Committee (or equivalent) to secure meaningful content, timely and impactful review, finalization, implementation and assignment of new or revised process documents to relevant roles within RA.
- For assigned processes and/or process area(s):
- o Lead Impact assessment, business process design, ownership, continuous improvement (including 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.
- o In partnership with International / Regions and Policy, monitor and review emerging regulations and regulatory guidelines and analyze impact on Novartis regulatory processes, and ensure outcome of the assessment is actioned (e.g. need to adapt a process).
- o Lead process changes in case of identified compliance issues (resulting from audit/inspection, QI, KPI trending)
- o Contribute to inspections and internal audits as Point of Contact for respective processes.
- o Provide direct input and expertise in the areas of process design, risk management, governance, organizational design and compliance, self-author/write or provide guidance to author(s) on the content of a procedural document
- o 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.
- o In partnership with the Systems team, incorporate technology portfolio deliverables into integrated transformation roadmap as well as any other non-drug development projects that impact the broadertransformation.
- o Contribute to the development of the learning & training strategy for enhancing regulatory capability building, functional learning and learning technology.
- Participate in or lead select cross-functional process related projects as applicable and on-need basis to support the overall roll-out of the RA organization.
- Monitor regulatory changes for processes in scope: Keep up-to-date with changes in regulations, industry trends, and evolving compliance standards. Partner with Capability / Learning Manager (as applicable) to disseminate relevant information and/or provide guidance on adapting to new requirements to relevant stakeholders.
- When designated, may represent RA at enterprise process community(ies) at and/or process/training governance boards
- Acts as deputy to Process Transformation Lead

Essential Requirements:

- Life Science Degree or other University degree with equivalent experience
- Significant regulatory and drug development experience
- Extensive knowledge on E2E process, supporting system, regulations and business change(s).
- Strong working knowledge of Quality Management System (QMS), SOPs and compliance
- Technology-savvy - ability to leverage and foster use of systems, technology and automation (including digital assistants and AI tools) to derive efficiency; embrace the mindset shift towards enhanced use of technology in daily work
- Ability to anticipate the impact of any change(s) from external and internal sources to the E2E process(es), supporting systems as applicable and to training
- Strong organizational awareness, including experience workingcross-functionally
- Ability to lead teams in a matrix environment
- Superior negotiation, influencing and communication skills
- Desirable Requirements:
- Ability to define and interpreting metrics
- Strategic thinking; process simplification and optimization
- Strong process authoring/writing capabilities

Skills Desired

Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution

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