REQ-10058843
7月 25, 2025
Malaysia

摘要

#LI-Hybrid
Location: Selangor, Malaysia

Join our dynamic Regulatory Affairs team and play a key role in ensuring timely and compliant product registrations in Malaysia. As a Regulatory Affairs Executive, you will contribute to the development and submission of regulatory documentation, support cross-functional compliance efforts, and maintain strong relationships with internal and external stakeholders. This role is ideal for someone who thrives in a fast-paced, detail-oriented environment and is passionate about regulatory excellence in the pharmaceutical industry.

About the Role

Key Responsibilities:-

  • Support the preparation and submission of product registrations, progress reports, supplements, amendments, and periodic experience reports.
  • Ensure all registration activities comply with local pharmaceutical regulations and internal policies.
  • Maintain and update product licenses, including CMC, CDS, and safety documentation, in line with regulatory requirements and company strategy.
  • Ensure compliance with NP4, KRPIA Code of Conduct, and relevant laws for activities such as DRAGON updates, RMPs, promotional materials, and PMS reporting.
  • Collaborate with internal teams and external stakeholders to facilitate smooth regulatory processes.
  • Report technical complaints, adverse events, or special case scenarios related to company products within 24 hours.
  • Oversee the compliant distribution of marketing samples (where applicable).

Essential Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
  • 2–4 years of experience in regulatory affairs or pharmaceutical operations.
  • Strong understanding of local regulatory guidelines and global compliance standards.
  • Demonstrated ability to manage multiple projects and meet regulatory timelines.
  • Excellent analytical skills and attention to detail.
  • Effective collaboration and communication skills across cross-cultural teams.
  • Familiarity with clinical trials, regulatory documentation, and project planning tools.

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

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

Development
Innovative Medicines
Malaysia
Selangor
Research & Development
Full time
Regular
No

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

A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10058843

Regulatory Affairs Executive

Apply to Job
Research & Development Development Malaysia