We are seeking an experienced Regulatory Affairs Executive/Senior Executive to manage regulatory documentation, product registrations, and compliance activities. The ideal candidate will be responsible for preparing and submitting regulatory dossiers, ensuring compliance with applicable regulations, maintaining regulatory records, and coordinating with internal teams and regulatory authorities to secure timely approvals.

Key Responsibilities
Prepare, review, compile, and submit regulatory dossiers, applications, and supporting documentation.
Coordinate product registrations, renewals, amendments, and variations with relevant regulatory authorities.
Track regulatory submissions, approvals, and commitments to ensure timely completion.
Maintain regulatory documentation, licenses, certificates, and product registration records.
Review product labels, artwork, packaging materials, and promotional content for regulatory compliance.
Interpret applicable regulatory requirements and communicate updates to internal stakeholders.




Coordinate with cross-functional teams including Quality, R&D;, Manufacturing, Supply Chain, and Marketing to support regulatory activities.
Ensure compliance with local and international regulatory requirements, company policies, and applicable standards.
Support internal and external audits by providing regulatory documentation and compliance records.
Maintain regulatory databases and prepare periodic status reports and MIS.
Monitor changes in regulatory guidelines and assess their impact on existing and current products.
Respond to regulatory authority queries and ensure timely submission of required information.

Desired Candidate Profile

Education
Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related discipline.
Master's degree or relevant certification in Regulatory Affairs will be an added advantage.

Experience
Minimum 5 years of experience in Regulatory Affairs, Product Registration, o

📌 Regulatory Affairs Officer Mumbai (India)
🏢 Shield It Hygiene Services
📍 India