Regulatory Affairs Manager at Novartis

, , Vietnam -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

0.0

Posted On

13 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

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

Industry

Pharmaceutical Manufacturing

Description

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 Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

Manage regulatory compliance and ensure timely registration licenses and approvals from local authorities. Coordinate with internal departments and the Drug Administration of Vietnam to support product availability and lifecycle management.