Global Regulatory Affairs Director (Cardio-Metabolic)

Novartis; City Of London; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

A leading pharmaceutical company is seeking a Global Program Regulatory Director to lead global regulatory strategies for development and marketed products. The role requires significant experience in regulatory development and expertise in regulatory strategy. The ideal candidate will have strong leadership abilities and excellent communication skills, contributing to a diverse and inclusive work environment.

Qualifications

• Fluent in English; additional languages are a plus.
• Significant experience in regulatory and pharmaceutical development (Phases I-IV).
• Expertise in regulatory strategy, scientific data analysis, and HA guidance.
• Proven regulatory operations and compliance skills.
• Strong leadership and matrix management abilities.

Responsibilities

• Create high-quality global regulatory strategies and manage Health Authority interactions.
• Identify and communicate potential regulatory opportunities and risks.
• Offer strategic regulatory input on key development, labeling, and promotional documents.
• Lead interactions with regulatory and development management and external consultants.
• Maintain compliance with global regulatory requirements and internal policies.

Skills

Clinical Trials

Cross-Functional Teams

Drug Development

Lifesciences

Negotiation Skills

People Management

Problem Solving Skills

Regulatory Compliance

Risk Management

Strategy Execution

Education

Bachelor's or Master's in a science-based field

Advanced degrees preferred

Job description

Job Description Summary

#LI-Hybrid (12 days per month on-site)

Location: London (The Westworks), United Kingdom

Internal Job Title: Global Program Regulatory Director

Novartis is seeking a Global Program Regulatory Director (GPRD) to lead global regulatory strategies for development and marketed products. This role integrates inputs from health authorities and stakeholders to meet commercial and portfolio objectives. The GPRD identifies regulatory opportunities, develops contingencies, ensures strategy execution, leads regulatory subteams, and represents Regulatory Affairs on program and cross-functional teams.

Job Description

Major accountabilities

• Create high-quality global regulatory strategies and manage Health Authority interactions to achieve development and business objectives.
• Identify and communicate potential regulatory opportunities and risks, and develop mitigation strategies.
• Utilize regional expertise to define and execute global regulatory strategies and engage with Health Authorities.
• Offer strategic regulatory input on key development, labeling, and promotional documents.
• Oversee submission planning, guide contributing authors, and critically review submission documentation.
• Lead interactions with regulatory and development management and external consultants for strategic input.
• Provide strategic regulatory and development input into Business Development & Licensing due diligence evaluations.
• Maintain compliance with global regulatory requirements and internal policies, and coordinate regulatory compliance activities.
• Lead regulatory teams, provide feedback and coaching, and support the growth and development of subteam members.
• Manage regulatory submissions, portfolio transformation activities, and business and operational excellence tasks.

Minimum requirements

• Bachelor's or Master's in a science-based field; advanced degrees preferred.
• Fluent in English; additional languages are a plus.
• Significant experience in regulatory and pharmaceutical development (Phases I-IV).
• Expertise in regulatory strategy, scientific data analysis, and HA guidance.
• Significant experience with major submissions.
• Knowledge of post-marketing strategies and commercial awareness.
• Proven regulatory operations and compliance skills.
• Strong leadership and matrix management abilities.
• Excellent communication, influencing, and problem-solving skills.
• Ability to navigate organizational complexity effectively.

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

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