About the role

Aplyr's Quick Take

This role is about managing regulatory compliance and securing necessary licenses for pharmaceutical products in Vietnam. You'll be coordinating with various departments to ensure timely submissions and approvals, while also maintaining relationships with local regulatory authorities. It's an individual contributor role focused on strategic oversight and compliance.

Good fit

Ideal candidates have over 5 years of experience in regulatory affairs, particularly in drug registration. A background in pharmacy or medicine is preferred, along with strong communication and negotiation skills.

Worth noting

The company does not offer relocation support, so applicants must already be based in Vietnam. The role involves proactive engagement with local regulations, which may appeal to those who enjoy influencing policy.

Job Description Summary

Ensure of regulatory compliance and achieving registration licenses on time from local authority, in line with company’s objectives.
Location: Ha Noi
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Job Description

Key Responsibilities

Ensure of assigned registration submission and approval on time (new registration, renewal registration, variations including new site), in line with local commercial strategies.
Ensure regulatory compliance for a sustainable life-cycle management: safety label change, labeling, CMC, 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 for product’s availability on market.
Collaborate with commercial team for launching preparation, tender management and promotional material management.
Ensure of regulatory database updated (DRAGON, REDI, RA Shared documents ...)
Develop and maintain effective working relationships with Drug Administration of Vietnam and key Stakeholders 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 Stakeholders 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.
Perform other tasks relating to Regulatory activities as assigned.

Minimum Requirements

University graduate, preferably with a degree in Pharmacy or Medicine
Fluent in English and Vietnamese, enabling effective local and global collaboration
5+ years of experience in Drug Regulatory Affairs or Drug Registration Management
Strong critical and strategic thinking, with proven communication, influencing, and negotiation capabilities
Demonstrated independent and innovative mindset, solid understanding of product‑relevant bioscience, and ability to build trust‑based relationships with key regulatory authorities

Skills Desired

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

Skills & Tags

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.