Job Description

Designation: Senior Executive / Assistant Manager / Manager/ Sr. Manager (based on experience)
Industry: Pharmaceutical - API Manufacturing
Experience: 3-15 Years (flexible)
Qualification: M.Sc (Chemistry) or equivalent
Key Responsibilities:
Prepare, compile, review, and submit regulatory dossiers for APIs for Regulated markets.
Handle DMF (Type II), ASMF, CEP, and CTD/eCTD submissions.
Manage regulatory submissions for markets such as USFDA, EDQM, EMA, WHO, CDSCO, TGA, PMDA, ANVISA, etc.
Prepare and submit variations, amendments, renewals, and responses to regulatory queries.
Coordinate with R&D, QA, QC, Production, and Analytical teams for dossier data collection.
Review process changes, impurity profiles, stability data, and assess regulatory impact.
Support regulatory inspections and audits related to API filings.
Maintain regulatory compliance with current global guidelines (ICH, FDA, EMA).
Track changes in global regulatory requirements and update internal stakeholders.
Maintain and archive regulatory documentation as per SOPs.
Required Skills & Competencies:
Strong knowledge of API regulatory submissions and lifecycle management.
Hands-on experience with DMF/CEP filings is mandatory.
Understanding of ICH guidelines (Q1-Q14) and regulatory frameworks.
Ability to interpret technical data related to synthesis, impurities, and specifications.
Excellent coordination and documentation skills.
Exposure to eCTD tools is an added advantage.
Preferred Experience:
Experience working with regulated market API filings.
Prior exposure to multiple authorities and complex submissions.
API manufacturing company background preferred.

Skills Required