JB-601 – Assistant Manager, Regulatory Affairs
This is a remote position.
Job Description
Act as accountable owner for CTD Modules 2.3.S, 2.3.P, 3.2.S, and 3.2.P.
Govern review and approval of formulation, QC, and manufacturing CTD content.
Define dossier-level regulatory strategy for assigned global markets.
Ensure consistency across DMF linkage, stability data, and quality sections.
Review and approve PVP, PVR, MFR, and process validation summaries.
Conduct dossier readiness reviews and structured internal technical reviews.
Review and authorise responses to regulatory authority technical queries.
Coordinate and guide Senior Executives across formulation, QC, and production.
Ensure compliance with ICH CTD structure and country-specific requirements.
Maintain audit-ready approval trails and regulatory traceability records.
Requirements
Requirements
Bachelor’s or Master’s degree in Pharmacy is mandatory.
Minimum six years experience in CTD dossier review or governance roles.
Prior exposure to LATAM, ASEAN, or Francophone Africa markets preferred.
Demonstrated expertise in CTD Modules 2 and 3 review ownership.
Proven ability to manage structured technical reviews across remote teams.
Benefits
Benefits
Work from home or office based on regulatory responsibilities.
Flexible schedule with defined dossier ownership and authority.
Direct involvement in multi-country, inspection-ready submissions.