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.