RA Submission Production Capability Lead

Job Description Summary

Office Location: London (The Westworks), United Kingdom
#LI-Hybrid Hybrid (12 days per month on-site if living within 50 miles to our London office)
#LI-Remote Remote (if living beyond 50 miles to our London office)
As the Submission Production Capability Lead, you’ll help shape the strategic vision of Regulatory Affairs and drive its digitalisation by overseeing key products that enable the creation, validation, and electronic delivery of regulatory submissions. You will ensure seamless submission production, structured data transfers, and gateway connectivity, while leading a strategy that delivers business value and promotes harmonisation, innovation, and continuous improvement.

 

Job Description

Major Accountabilities:

• Lead a team to ensure alignment with organizational goals and business priorities related to Submission Production.
• Support the strategic vision for the Submission and Registration 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.
• Define, prioritize, and deploy an integrated capability roadmap working in close collaboration with relevant stakeholders and DDIT partners, ensuring alignment with the Submission & Registration Platform, Development and Enterprise technology strategy roadmaps.
• 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.

Minimum Requirements:

• Relevant industry experience.
• Strong understanding and direct relevant experience with  the data and technology landscape of pharmaceutical regulatory affairs.
• Strong strategic problem-solving skills and ability to navigate un-charted territory without clear precedent.
• Experience presenting/speaking at a senior management level with a proven track record of effectively communicating complex initiatives.
• Demonstrated leadership skills with a proven track record of successfully managing people.
• Demonstrated leadership in driving risk assessment and mitigation, clear strategic thinking, prioritization, maintaining awareness of business impact.
• Strong negotiation skills.
• Excellent verbal and written communications.
• Experience with processes, systems & tools related to Submission Production activities.

Commitment to Diversity and Inclusion/EEO:

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

 

Skills Desired

Data Analysis, Documentation Management, Lifesciences, Proactivity, Process Improvement, Regulatory Compliance, Waterfall Model