Head Regulatory Affairs Strategy Office

$245,600 - $368,400/Yr

U014 (FCRS = US014) Novartis Pharmaceuticals Corporation - East Hanover, NJ

Full-time - Senior

East Hanover, NJ

About the position

The Pivotal Enterprise Leader in Global Regulatory Affairs at Novartis will shape and execute strategies to enhance the Regulatory Affairs function, ensuring alignment with organizational goals and stakeholder needs. This role involves overseeing regulatory activities, analyzing key performance indicators, and leading value-based projects to foster an agile culture within Regulatory Affairs. The leader will act as a liaison with the RA Leadership Team and stakeholders, driving collaboration and coaching talent to achieve optimal outcomes in regulatory processes.

Responsibilities

• Define strategic vision and objectives for Regulatory Affairs in collaboration with the leadership team.
• Oversee Regulatory Affairs activities to fulfill drug portfolio commitments and assess associated risks.
• Provide expert advice to the Leadership Team and business leaders, driving prioritization decisions for initiatives.
• Monitor project timelines, resources, and risks to ensure successful completion aligned with organizational goals.
• Analyze data and KPIs to identify regulatory trends and inform decision-making for Regulatory Affairs and Development.
• Shape and mobilize strategic internal projects with stakeholders, ensuring clear governance and resource allocation.
• Facilitate change management for the Regulatory Affairs function, ensuring smooth transitions during periods of change.
• Partner with RA Finance for accurate ongoing reporting and budget planning.

Requirements

• Advanced degree or equivalent experience in a relevant field.
• Minimum of 10 years in global strategy, innovation, or management consulting, with preferred experience in Regulatory Affairs.
• Demonstrated ability to create strategic objectives based on assessments.
• Project management expertise with strong portfolio management experience.
• 5 years of experience in global matrix people management, with direct people management experience preferred.
• Excellent communication and presentation skills, capable of engaging at all levels.
• Ability to recruit and foster a culture of high performance.

Nice-to-haves

• Experience in the pharmaceutical or biotechnology industry.
• Familiarity with regulatory compliance and submission processes.
• Strong analytical skills to interpret complex data and trends.

Benefits

• 401(k) eligibility
• Paid time off benefits including vacation, sick time, and parental leave
• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Comprehensive medical benefits