Executive regulatory Affairs

Key Responsibilities:

• Prepare and compile dossiers for submission to regulatory authorities (CTD/eCTD formats).
• Ensure timely submission and tracking of product registration, variations, renewals, and other regulatory filings.
• Coordinate with cross-functional departments (R&D, QA, QC, Manufacturing) to gather technical documents for submissions.
• Maintain regulatory databases, records, and document control systems.
• Communicate with regulatory bodies and respond to queries/deficiency letters in a timely and accurate manner.
• Review product labels, artworks, and promotional materials for regulatory compliance.
• Keep up to date with changes in regulatory guidelines and ensure the company's compliance accordingly.
• Support audits and inspections by providing required regulatory documentation.
• Participate in regulatory strategy planning for new products and markets.

Qualifications:

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• 14 years of experience in Regulatory Affairs, preferably in the pharmaceutical or healthcare sector.
• Knowledge of country-specific regulatory requirements (India, US, EU, ROW, etc.)

Key Skills:

• Knowledge of regulatory submission formats (CTD, eCTD).
• Understanding of global regulatory frameworks (USFDA, EMA, CDSCO, WHO-GMP, ICH).
• Strong documentation and technical writing skills.
• Attention to detail, organizational, and project management skills.
• Proficiency with regulatory databases or document management systems.
• Effective communication and interpersonal skills.