DRA Manager

Drlogy; Panchkula; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Drlogy is seeking an experienced DRA Manager in Panchkula, Haryana, responsible for managing drug regulatory affairs activities and ensuring compliance within pharmaceutical operations. The role involves preparing regulatory submissions, coordinating with authorities, and monitoring changes in regulations. Candidates should be adept at dossier preparation and compliance management, along with a strong focus on timely approvals and adherence to international standards. This position supports business expansion through necessary regulatory approvals and market access.

Responsibilities

• Manage regulatory affairs and product registration activities.
• Prepare and review regulatory dossiers and submission documents.
• Coordinate with regulatory authorities for approvals and compliance.
• Ensure compliance with domestic and international regulations.
• Monitor changes in regulatory guidelines and industry standards.
• Coordinate with QA, production, and R&D teams for submissions.
• Review product labeling and packaging compliance requirements.
• Handle regulatory queries and deficiency response activities.
• Maintain records related to licenses and product registrations.
• Support audits and regulatory inspection activities.
• Monitor submission timelines and approval status regularly.
• Implement regulatory strategies for product lifecycle management.
• Ensure proper documentation and compliance reporting activities.
• Train teams on regulatory requirements and compliance standards.
• Support business expansion through regulatory approvals and market access.

Job description

Experienced DRA Manager responsible for managing drug regulatory affairs activities, product registration processes, and regulatory compliance within pharmaceutical operations. Skilled in dossier preparation, regulatory submissions, compliance management, and coordination with regulatory authorities. Adept at ensuring timely approvals and maintaining adherence to international pharmaceutical regulations.

Responsibilities

• Manage regulatory affairs and product registration activities.
• Prepare and review regulatory dossiers and submission documents.
• Coordinate with regulatory authorities for approvals and compliance.
• Ensure compliance with domestic and international regulations.
• Monitor changes in regulatory guidelines and industry standards.
• Coordinate with QA, production, and R&D teams for submissions.
• Review product labeling and packaging compliance requirements.
• Handle regulatory queries and deficiency response activities.
• Maintain records related to licenses and product registrations.
• Support audits and regulatory inspection activities.
• Monitor submission timelines and approval status regularly.
• Implement regulatory strategies for product lifecycle management.
• Ensure proper documentation and compliance reporting activities.
• Train teams on regulatory requirements and compliance standards.
• Support business expansion through regulatory approvals and market access.