353497BR
Sep 22, 2022
Vietnam

Job Description

4! The 4 essential elements that shape our culture: Inspired. Curious. Unbossed. Integrity. Our mission is to discover new ways to improve and extend peoples’ lives. Your passion to build, implement business plans to meet the sales goals, develop effective professional business relationships with Healthcare Professionals will help the world understand what these medicines do, why they matter and how Novartis is striving to reimagine medicine.

As Regulatory Affairs Executive, you will achieve regulatory compliance and obtain registration licenses on time from local authority, in line with company’s objectives.

Your Responsibilities:
Your responsibilities include, but not limited to:

• Ensure registration submission and approval on time (new registration, renewal registration, variations), in line with local commercial strategies, for assigned products
• 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
• Packaging Artwork Development & coordinate with AW/plant’s/local QA/SC colleagues for packaging materials of products in responsible portfolio.
• 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 Health Authority to support current and future business activities (which are under responsibility of Regulatory Affairs).
• Ensure compliance of organization to current local regulations: Awareness of current and new local regulations. Communication of any changes that may impact Novartis in a timely manner to all relevant Partners. Partner with relevant stakeholders to ensure timely implementation of new regulations; Perform other tasks relating to Regulatory activities as assigned.

Diversity & Inclusion / EEO

Novartis is 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 graduate. Degree in pharmacy or medicine preferred
• Proficient in English
• Knowledge of the Pharma regulatory environment
• Ability to develop trust-based relationships with key regulatory officials; Good interpersonal communication and influencing skills; Good negotiation ability
• Independent and innovative orientation; Good analytical skills; Good understanding of product-relevant bioscience; Teamwork

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
Global Drug Development
REG AFFAIRS GDD
Vietnam
Ha Noi
Research & Development
Full Time
Regular
No
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353497BR

Regulatory Affairs Executive_ Ha Noi

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