Regulatory Affairs Process Manager

ZipRecruiter; Dalkeith; Hybrid; GBP 100,000 - 125,000

Job description

Job Description

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the + business community. Please do not contact the recruiter directly.

Summary: Responsible for the development and implementation - including adequate training to staff, efficiency, gap assessment and continuous improvement and performance - as well as operational support of assigned regulatory processes, as applicable and in close collaboration with the Process Director and other functions as applicable, to ensure organizational readiness and compatibility with associated systems and technology and compliant with global regulatory requirements and Novartis standards.

About the Role

Major accountabilities

• 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 (e.g. SOP, WP, BPG), adhering to industry standards. SOP operational management (e.g. 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.

This role will be hybrid, requiring 3 days per week in our London office.

Experience and skills

• 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? Learn more.

Commitment to Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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