Compliance Manager reviewing broker - dealer and registered investment adviser communications for regulatory compliance. Working collaboratively with diverse business partners in a hybrid work environment.
About the role
- Global Regulatory Affairs Director at Novartis leading regulatory strategies for development and marketed products. Involves managing submissions and team leadership, ensuring regulatory compliance.
Responsibilities
- 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.
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.
Benefits
- Hybrid (12 days per month on-site if living within 50 miles to our London office)
- Remote (if living beyond 50 miles to our London office)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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