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Regulatory Affairs Specialist
4 weeks ago
This is a full-time, on-site position based in New Delhi for a Regulatory Affairs Specialist. The role involves effective communication and coordination with both internal teams and external stakeholders to ensure regulatory compliance and smooth operational workflows.
Key Responsibilities:
Develop and implement procedures to ensure regulatory compliance across all functions.
Lead the Regulatory and Quality departments by building systems, competencies, and structure.
Keep up to date with evolving national and international regulations and guidelines.
Ensure seamless coordination between Regulatory/Quality and other teams from product planning to government approvals.
Manage timelines for various regulatory submissions including license applications, renewals, and clearances.
Prepare and oversee accurate submission documentation in collaboration with principals and distributors for domestic and international registrations.
Represent the organization in front of regulatory authorities (CDSCO, DGHS, DAHD, DCA, FSSAI, CPCB, etc.).
Maintain readiness for audits and inspections; ensure compliance with regulatory and QMS standards.
Oversee post-marketing surveillance activities, including FSCA, complaint handling, recalls , and reporting of adverse events.
Review promotional material and packaging for regulatory compliance.
Manage regulatory documentation, specifications, and internal SOPs.
Conduct regular training for the team across divisions to comply with regulatory requirements as per company requirements on Regulatory Domain.
Ensure timely registration and licensing of all products and instruments.
Coordinate and communicate with principal companies for product registrations and updates. Approve Purchase Orders from a regulatory perspective before shipment to India.
Skills & Competencies:
Strong understanding of Indian and global regulatory frameworks (CDSCO, DGHS, IVD regulations, etc.).
Experience in handling licensing, audits, product registrations, and compliance documentation.
Ability to interpret and implement regulatory requirements effectively.
Strong communication and stakeholder management skills.
Proficiency in preparing regulatory documentation and coordinating with government authorities.
Attention to detail and excellent organizational skills.
Experience with QMS implementation and compliance.
Familiarity with legal metrology, labeling, and MRP compliance.
Qualification:
Degree in BPharm / M.Pharma / Biotech or any Biological Sciences with a strong knowledge and experience of regulatory domain.
Experience:
3-7 years experience
Experience working with the CDSCO Department
