Prepare, review, and compile CMC (Chemistry, Manufacturing, and Controls) sections of regulatory dossiers for peptide and injectable formulations.

Manage submissions for ANDA, NDA, DMF, CTD/eCTD formats for global markets (USFDA, EMA, WHO, etc.).

Ensure timely regulatory approvals, renewals, and variations.

Evaluate and interpret regulatory guidelines for peptides and sterile dosage forms to ensure compliance.

Liaise with R&D, QA, QC, Manufacturing, and Project Management teams to support product development and lifecycle management.

Maintain up-to-date knowledge of global regulatory requirements for peptides and injectables.

Handle queries from health authorities, provide technical justifications, and support audit readiness.

Oversee labeling, packaging, and artwork approvals for regulatory submissions. Education: M.Pharm / M.Sc in Pharmaceutical Sciences, Chemistry, or related field.

Experience: 812 years in Formulation Regulatory Affairs, with at least 35 years in peptide or injectable products.

Strong knowledge of CMC documentation, eCTD submissions, and regulatory databases.

Experience in USFDA, EMA, and other international regulatory filings.

Excellent understanding of ICH, WHO, and country-specific guidelines.

Proficient in technical writing, data interpretation, and document review.

Strong interpersonal, communication, and leadership skills.