Regulatory Affairs
Job Title: Regulatory Affairs Manager
Location: Egmore, Chennai
CTC: Best in Industry (Based on Experience)
Experience: Minimum 3 or 3+ years in Regulatory Affairs (Pharma/Medical Device industry)
Education: Bachelor’s degree in a scientific discipline; advanced degree preferred
Joining: Immediate joiner preferred
Job Summary:
We are seeking a Regulatory Affairs Manager to lead compliance and submission strategies
for pharmaceutical and medical device products. The ideal candidate will ensure adherence to
global and local regulations, manage audits, oversee regulatory submissions, and collaborate
across functions to drive regulatory excellence.
Key Responsibilities:
● Oversee regulatory compliance, strategy development, and submission management
● Ensure timely regulatory filings, audits (e.g., MDSAP, ISO 13485), and GMP support
● Manage product registration, labeling compliance, and market approvals
● Collaborate with cross-functional teams to align regulatory support with product goals
● Maintain strong relationships with regulatory authorities and external stakeholders
Required Skills:
● In-depth knowledge of regulatory processes (FDA, EMA, CDSCO, etc.)
● Proficiency in MS Office, strong technical documentation & project management skills
● Excellent communication, leadership, and problem-solving abilities
● Experience in the pharma or medical device industry is essential
Join our growing team and make a real impact in delivering compliant and innovative healthcare solutions.
📩 Apply now to be part of a mission-driven organization!
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