Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
About the role
- Global Program Regulatory Director responsible for regulatory strategies at Novartis, integrating inputs from health authorities and stakeholders to meet commercial objectives.
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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