摘要
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? https://www.novartis.com/about/strategy/people-and-culture
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
