Regulatory Affairs Knowledge Management Capability Lead

Posted 11 Days Ago
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West Hampstead, London, England, GBR
In-Office
68K-126K Annually
Senior level
Biotech • Pharmaceutical
The Role
Lead the Regulatory Affairs Knowledge Management capability: define strategy and roadmap, drive adoption and change management, oversee product(s), vendor integrations, stakeholder governance, compliance and audit readiness, and ensure high-quality delivery and alignment with enterprise platforms.
Summary Generated by Built In

Salary Range:

£67,900.00 - £126,100.00

Job Description Summary

Job Description Summary
#LI-Hybrid (12 days per month on-site if living within 50 miles of our London office)
#LI-Remote (Homeworker if living further than 50 miles of our London office)
Office Location: London (The Westworks), United Kingdom
As a member of the Knowledge & Content Management Platform team, the Knowledge Management Capability Lead contributes to the strategic vision of Regulatory Affairs and supports the digitalization and centralization of Knowledge Management in RA, by overseeing one or several product(s) underlying the Capability.
The Knowledge Management Capability is supporting knowledge gathering and sharing across the organization, as well as the leveraging of collaboration tools. This capability is defining the strategy for successful deployment and usage of knowledge management technologies, best practices, and advising on information structure. The capability is also supporting regulatory requirements gathering and availability, as well as advocating for an harmonized approach through the leveraging of state-of-the-art enterprise tools. The Capability should also ensure high user adoption & scale-up, and easy retrieval of information potentially leveraging Artificial Intelligence.
The Knowledge Management Capability Lead is accountable to ensure that the Capability strategy delivers business benefits, and to drive harmonization and continuous improvements.

Job Description

1. Team Leadership:

  • Responsible to ensure alignment of a team with organizational goals and business priorities related to Knowledge Management
  • Support the strategic vision for the Knowledge & Content Management Platform, from a Capability level
  • Act as a Change Lead to drive system adoption, communication and training, at the capability level: implement change management strategies to ensure smooth adoption of technology initiatives

2. Roadmap Development:

  • Define, prioritize, and deploy an integrated capability roadmap working in close collaboration with relevant stakeholders and DDIT partners, ensuring alignment with the Knowledge & Content Management Platform, Development and Enterprise technology strategy roadmaps

3. Stakeholder engagement:

  • Represent the Capability in digital governance boards and leadership meetings across the organization
  • Represent the Capability in digital networks, externally (e.g. across Industries) as needed
  • Communicate effectively to ensure understanding and support for new technology initiatives
  • Support continuous expansion of knowledge and foster the adoption of a digital mindset within the Regulatory Affairs team

4. Collaboration and Partnerships:

  • Build and maintain collaborative and productive partnerships within the Capability and the Platform, and with relevant stakeholders to achieve business priorities.
  • Oversee vendors at the capability level, across product(s), in collaboration with IT and the External Partnerships Teams
  • Oversee integrations with products underlying the Capability.

5. Quality and Compliance:

  • Ensure on-time, compliant, secure, and quality delivery of portfolio for the assigned capability/product(s), aligned with the NVS Quality Manual
  • Contribute to the change management strategy to ensure smooth adoption of technology initiatives, as required
  • Ensure adherence to Security and Compliance policies and procedures within the scope of the Capability, and prepare for audit readiness and inspection requirements (incl. Related mitigations or actions triggered by audits & inspections).

6. Product responsibility:

  • Responsible for Product(s) within the Capability. Can act as a product manager and a product owner
  • Ensure on time, compliant, secure, and quality delivery of portfolio for the assigned product(s), partnering with relevant IT functions.
  • Responsible to approve product-related requirements across product(s) underlying the Capability

7. Project and Program Support:

  • Responsible for configuration, decision making and outcome, impacting the capability, with involvement of relevant Business Process Owner(s), business SMEs and stakeholders
  • Provide support/resources for key projects and programs with impact to the underlying product(s), ensuring timely delivery of high-quality milestones in alignment with business requirements.
  • Collaborate with business, IT, etc. to develop and define project scope, objectives, interdependencies for projects related to the capability and underlying product(s).

8. Demand Management:

  • Effectively manage demand for technology services and operational support arising from various functions within Regulatory Affairs
  • Monitor service delivery performance and backlog

9. Industry Trends:

  • Stay updated with industry trends and emerging practices to drive agility, speed, efficiency, and effectiveness within the Capability

Benefits & Rewards 

 

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. 

  

Expected Annual Base Salary Range for role: £67,900 to £126,100

  

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. 

  

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. 

  

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. 

 

 

Commitment to Diversity and Inclusion / EEO paragraph 

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


 

Skills Desired

Clinical Trials, Detail-Oriented, Drug Development, Regulatory Compliance, Risk Management

Skills Required

  • Experience in Regulatory Affairs (pharma/biotech)
  • Proven knowledge management strategy and capability development
  • Change management and user adoption experience
  • Product management or product owner experience for enterprise products
  • Stakeholder engagement and representation in governance boards
  • Vendor management and oversight of third-party integrations
  • Experience ensuring compliance, audit readiness, and quality in regulated environments
  • Experience working with IT/enterprise platforms and overseeing integrations
  • Familiarity with knowledge retrieval approaches and leveraging AI for search/knowledge discovery
  • Strong communication, training, and leadership skills to align teams and deliver roadmaps
  • Domain skills desired: Clinical Trials, Drug Development, Regulatory Compliance, Risk Management

Novartis Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.

  • Healthcare Strength Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
  • Retirement Support Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
  • Parental & Family Support Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.

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The Company
HQ: Basel
110,000 Employees
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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