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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Division Development Business Unit Innovative Medicines Location Malaysia Site Selangor Company / Legal Entity MY01 (FCRS = MY001) Novartis Corporation (Malaysia) Sdn. Bhd. (19710100054) Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Apply to JobNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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