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).
Qualifications
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.
