Assistant Manager – Regulatory Affairs

This is a fully remote position, open to applicants in India.

📋 Description

• Serve as the accountable owner for CTD Modules 2.3.S, 2.3.P, 3.2.S, and 3.2.P.

• Oversee the review and approval processes for formulation, QC, and manufacturing CTD content.

• Establish regulatory strategies for dossiers tailored to designated global markets.

• Ensure alignment across DMF linkage, stability data, and quality sections.

• Evaluate and approve PVP, PVR, MFR, and process validation summaries.

• Conduct readiness assessments of dossiers and structured internal technical reviews.

• Review and authorize responses to technical inquiries from regulatory authorities.

• Coordinate and provide guidance to Senior Executives in formulation, QC, and production.

• Ensure adherence to ICH CTD structure and country-specific regulations.

• Maintain audit-ready approval trails and records for regulatory traceability.

⛳️ Requirements

• A Bachelor’s or Master’s degree in Pharmacy is essential.

• A minimum of six years of experience in CTD dossier review or governance roles is required.

• Previous experience in LATAM, ASEAN, or Francophone Africa markets is preferred.

• Proven expertise in the ownership of CTD Modules 2 and 3 reviews.

• Demonstrated capability to facilitate structured technical reviews across remote teams.

🏝️ Benefits

• Option to work from home or at the office depending on regulatory duties.

• Flexible working hours with clearly defined dossier ownership and authority.

• Direct participation in multi-country, inspection-ready submissions.