Regulatory Affairs Manager

Job Description Summary

Location: Hanoi

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About the Role

As a Regulatory Affairs Manager in Vietnam, you are the strategic bridge between innovation and patient access. You will lead the charge in securing and maintaining marketing authorizations for a diverse portfolio of life changing medicines, ensuring compliance with both global standards and Vietnam's evolving regulatory landscape.

This role is supporting and ensuring that registration milestones of global and regional projects/brands are met, and functional excellence including compliance is achieved. Supports RA CO Head in developing registration strategies including business continuity by obtaining and maintaining all marketing authorizations of products under responsibility. Contributes to converting new regulatory policy into tangible regulatory strategies, including interfacing with external stakeholders.

This position to be based in Hanoi.

Key Responsibilities

• Ensure assigned product portfolio registration submission and approval on time (new registration including new site, renewal registration, variations), in line with local commercial strategies.
• Ensure regulatory compliance for a balanced life cycle management: safety label change, labeling, CMC, RMPs, PSUR and other MA lifecycle support are performed in accordance with local regulations and relevant Novartis SOPs.
• Coordinate with QA/Supply chain departments to support product's availability on market.
• Develop and maintain effective working relationships with Drug Administration of Vietnam and key Partners to support current and future business activities (which are under responsibility of Regulatory Affairs).
• Proactively involve on shaping regulation as assignment by time.
• Ensure compliance to current local regulations: Awareness of current and new local regulations. Interpretation and communication of any changes that may impact Novartis in a timely manner to all relevant Partners as per assignment to ensure timely implementation of new regulations and reflect on business strategy.
• Ensure adherence to Global and local processes & Process improvements: Compliance with Global processes and proactively identify areas of improvement with regards to local compliance.
• Ensure maintenance of DRA Regulatory database: correct and timely DRA Regulatory database in Global systems and Local record; Perform other tasks relating to Regulatory activities as assigned.

Essential Requirements

• University degree or equivalent experience in Pharmacy.
• Minimum 5 years' experience in Drug Regulatory Affairs in MNC or Drug Administration of Vietnam.
• Critical thinking with attention to detail; Analytical and problem solving skills; Written and oral communication skills; Influencing & negotiation skills.
• Language: English & Vietnamese.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired

Clinical Trials, Detail Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance.