Job Title:
Regulatory Affairs Specialist – Dossier Preparation & ROW Markets
Location
: Malad (west), Mumbai
Job Summary:
The Regulatory Affairs Specialist will be responsible for the preparation, compilation, and submission of regulatory dossiers in CTD/ACTD formats for various international markets. This role involves reviewing technical documents, responding to MOH queries, and ensuring compliance with regulatory requirements across diverse regions.
Key Responsibilities:
Dossier Preparation & Submission:
Compile and submit regulatory dossiers (CTD/ACTD/Country specific index formats) for product registrations in ROW markets.
Coordinate with cross-functional teams to gather necessary documentation for submissions.
Ensure timely submission of applications in accordance with country-specific regulatory guidelines.
Document Review & Compliance:
Review technical documents, including batch records, specifications, analytical methods, and validation reports, to ensure accuracy and compliance.
Assess and approve labeling, packaging materials.
MOH Queries & Communication:
Act as the primary liaison with regulatory authorities, addressing queries and providing necessary clarifications.
Prepare and submit responses to deficiency letters or requests for additional information in a timely manner.
Qualifications:
Bachelors or Master’s degree in Pharmacy, Life Sciences, or a related field.
2–5 years of experience in regulatory affairs, specifically in dossier preparation and submissions for international markets.
Proficiency in CTD/ACTD/ Country specific index formats and familiarity with regulatory requirements of ROW countries.
Strong understanding of regulatory guidelines and ability to interpret technical documents.
Excellent communication and interpersonal skills for effective coordination with internal teams and regulatory authorities.
