Job Description
Are you passionate about driving regulatory compliance and operational efficiency across international markets Join us as the International Regulatory Excellence Director (IRED) and play a pivotal role in shaping regulatory strategies, optimizing processes, and ensuring the highest standards of compliance across our international operations.
Key Responsibilities:-
- Provide strategic guidance and regulatory expertise to country regulatory operations in your assigned region.
- Drive the design and implementation of local and regional regulatory processes to enhance efficiency and compliance.
- Lead and support regional regulatory actions to enable business operations and address compliance topics.
- Partner with global and country teams to resolve quality events, inspections, and audits, and implement preventive risk management measures.
- Represent the region in global cross-functional initiatives, ensuring local needs are reflected in global processes and tools.
- Guide and support process redesign and change management at country and regional levels.
- Oversee regulatory KPIs/KQIs, analyze data, and drive remediation actions to achieve compliance targets.
- Lead or support initiatives to optimize working models and implement global compliance strategies.
- Support inspection readiness, quality incident management, and self-assessment activities across the region.
- Provide input to global training requirements and drive capability-building initiatives.
Essential Requirements :-
- Minimum 10 years experience in Pharma, Regulatory Affairs, Quality Assurance, Audit/Inspection management, Risk Management, or Project Management.
- Extensive knowledge of worldwide regulations, guidelines, and regulatory processes.
- Proven ability to drive outcomes and lead cross-functional teams in a matrix environment.
- Demonstrated success in process simplification, optimization, and change management.
- Advanced analytical skills with the ability to interpret data and predict process/system impacts.
- Excellent interpersonal, communication, influencing, and negotiation skills.
- Strong quality focus and experience in data analytics and risk management.
- Intercultural experience and ability to thrive in a complex, rapidly changing business environment.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
