Global Regulatory Affairs Director (Global Program Regulatory Director)
#LI-Hybrid (3 days per week on-site)
Location: London (The Westworks), United Kingdom or Dublin, Ireland
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.
- 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.
Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution
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