Regulatory Affairs Specialist

2 days ago

Palakkad, Kerala, India Profile HR Consultants Pvt Ltd Full time
Company Overview:
Profile HR Consultants Pvt Ltd is a leading recruitment agency that specializes in providing top talent to the pharmaceutical industry. Our clients include major pharma organizations that operate globally, serving regulated markets and developing economies.

Job Description:
We are currently seeking an experienced Regulatory Affairs Specialist to join our client's team. This individual will be responsible for managing day-to-day regulatory operations, ensuring compliance with Good Regulatory Practices (GRP) and cGMP best practices. The successful candidate will also be responsible for maintaining regulatory documentation, coordinating with government agencies, and filing submissions through online portals.

Key Responsibilities:
• Manage day-to-day regulatory operations, including quality assurance and implementation
• Maintain regulatory and QMS documentation in line with cGRP and cGMP regulations
• Coordinate with government agencies, including State FDA and CDSCO
• File submissions through online portals, such as SUGAM
• Participate in regulatory audits, including WHO, CDSCO, and TFDA

Requirements:
• 10 years of experience in Quality Assurance and Regulatory Affairs
• Extensive experience in managing regulatory affairs for formulations and APIs
• Comprehensive understanding of regulatory requirements from US FDA, ANVISA, MHRA, TGA, EMEA, and MCC
• Familiarity with cGMP, ICH GCP, and GLP guidelines
• Experience in preparing and reviewing dossiers for regulatory submissions

Benefits:
Our client offers a competitive annual compensation package of ₹20 lakhs. If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please apply.

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