Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Major accountabilities:

• Lead the implementation of regulatory strategies and operational activities across major global regions.
• Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents.
• Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.
• Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials.
• Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans).
• Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals.
• Develop and implement strategies to minimize review delays and regulatory clock stops.
• Ensure timely and compliant responses to HA queries and requests.
• Contribute to departmental goal setting and lead initiatives to improve regulatory processes.
• Ensure adherence to internal policies, SOPs, and global regulatory requirements.

Minimum requirements:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
• Significant experience in regulatory affairs within the pharmaceutical industry.
• Proven track record in project management and regulatory operations.
• Experience representing the organization in cross-functional and cross-cultural settings.
• Strong knowledge of clinical trials, drug development, and regulatory compliance.
• Excellent problem-solving, negotiation, and communication skills.
• Detail-oriented with the ability to manage complex regulatory projects.
• Skilled in risk management and working with cross-functional teams.
• Ability to navigate and influence Health Authority interactions.
• Fluency in English (written and spoken) is essential.

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.