Executive Regulatory Affairs

Job Description:

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.

Qualification & Experience

• 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.