Regulatory Affairs Executive

Healthcare Businesswomen’s Association; Selangor; Hybrid; MYR 60,000 - 80,000; Full time

Job summary

A healthcare organization in Selangor, Malaysia is seeking a Regulatory Affairs Executive to support product registrations and ensure compliance with local regulations. The ideal candidate will have a strong understanding of regulatory affairs and experience in pharmaceutical operations. Excellent analytical skills and collaboration abilities are essential. This is a hybrid position that promotes a diverse and inclusive work environment.

Qualifications

• 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.
• Effective collaboration and communication skills across cross-cultural teams.

Responsibilities

• Support the preparation and submission of product registrations and reports.
• Ensure compliance with local pharmaceutical regulations and internal policies.
• Collaborate with internal teams and external stakeholders for regulatory processes.

Skills

Analytical Skill

Detail-Oriented

Collaboration

Regulatory Compliance

Clinical Trials

Project Planning

Education

Bachelor’s degree in Life Sciences, Pharmacy, or a related field

Job description

Job Description Summary

#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.

Job Description

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

Skills Desired

Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance