International Regulatory Excellence Director

Job Description Summary

Job Description

Major accountabilities:

• Accountable that country/regional regulatory requirements and perspective are represented and acknowledged during global process design or update. Represents RA International countries on global regulatory process review and approval boards global cross functional initiatives and committees whenever required.

• Is accountable to build a structured network of active stakeholders across International countries and global functions to address potential quality issues / emerging compliance and recommend solutions.

• Provides guidance and support to country operations during design of local or regional processes. Supports countries in evaluating and implementing changes to local or regional processes stemming from various sources including but not restricted to changes in the regulatory legislation internal tools and business practices.

• Ensures an up-to-date curricula for regional roles and supports country regulatory teams in designing country level roles and curriculae.

• Lead and / or support initiatives to optimize working models and compliance in their assigned region. Ensure implementation of global RA compliance strategies and cross-functions risk management framework across International countries thereby further enhancing core business processes at the country level.

• Support the management of local or regional Quality Incidents/Quality Events - perform investigation root cause analysis support CAPA preparation and effectiveness checks across countries in International as needed. Ensure Inspection readiness.

• Support to local CO audits / inspection / self-assessment in regions as needed.

• Responsible for escalating issues to management as necessary and according to process.

Essential Requirements:

• Bachelors science-based degree required with requisite experience and demonstrated capability. Higher degree preferred.

• Fluent in English. Other languages is an advantage.

• A wealth of experience in Pharma Regulatory Affairs Quality Assurance Audit/Inspection management support Risk Management Project Management.

• Extensive knowledge and experience of worldwide regulations guidelines and regulatory processes.

• Advanced ability to drive outcomes in cross-functional teams in a matrix environment.

• Proven records of process simplification and optimization.

• Advanced analytical skills and ability to understand/predict impact of process and systems

• Proven records of excellent interpersonal communication influencing and negotiation skills and proven ability to work effectively in a cross-functional and international matrix environment.

• Highly experienced in change management intercultural experience and ability to act in a complex and rapidly changing business environment.

• Strong quality focus influencing communication skills and experience in data analytics and risk management.

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.

Skills Desired