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Regulatory Affairs Manager

2 months ago

Hanoi, Vietnam Novartis Full time

As Regulatory Affairs Manager, you will ensure of regulatory compliance and achieving registration approval on time from local authority, in line with company’s objectives.
Your responsibilities include, but not limited to:

- Ensure of 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 sustainable 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 for product’s availability on market.
- 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.
- 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.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

What you’ll bring to the role:

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

**Division**

Global Drug Development

**Business Unit**

REG AFFAIRS GDD

**Country**

Vietnam

**Work Location**

Ha Noi

**Company/Legal Entity**

NVS Vietnam Company Limited

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes

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