Regulatory Affairs Junior Officer to Deputy Manager

Drlogy; Vadodara; On-site; INR 400,000 - 600,000; Full time

Job summary

Drlogy seeks a Regulatory Affairs Junior Officer to Deputy Manager in Vadodara, India. The role involves preparing and reviewing regulatory documentation for pharmaceutical products, ensuring compliance with local and international regulations. Key responsibilities include dossier preparation, coordination with regulatory authorities, and monitoring updates in regulations. Ideal candidates should be detail-oriented and skilled in navigating complex regulatory environments. The position offers a chance to work closely with QA, QC, production, and R&D teams.

Qualifications

• Experience in preparing and maintaining regulatory documentation.
• Skilled in coordinating with regulatory authorities.
• Knowledge of local and international pharmaceutical regulations.

Responsibilities

• Prepare and compile regulatory dossiers for product registrations.
• Coordinate approvals and compliance requirements with authorities.
• Review labeling, packaging, and artwork for compliance.

Skills

Detail-oriented

Dossier preparation

Regulatory submissions

Product registration

Compliance coordination

Job description

Regulatory Affairs Junior Officer to Deputy Manager

Detail-oriented Regulatory Affairs Executive responsible for preparing, reviewing, and maintaining regulatory documentation for pharmaceutical products in compliance with domestic and international guidelines. Skilled in dossier preparation, regulatory submissions, product registration, and compliance coordination. Experienced in working with cross-functional teams to ensure timely approvals, regulatory adherence, and successful lifecycle management of pharmaceutical products.

• Prepare and compile regulatory dossiers for product registration submissions.
• Coordinate with regulatory authorities for approvals and compliance requirements.
• Maintain regulatory documentation and product registration records accurately.
• Review labeling, packaging, and artwork for regulatory compliance.
• Monitor updates in pharmaceutical regulations and industry guidelines.
• Support product lifecycle management and variation filing activities.
• Coordinate with QA, QC, production, and R&D teams for submission requirements.
• Prepare responses to regulatory queries and deficiency letters.
• Ensure compliance with local and international regulatory standards.
• Maintain databases related to licenses, approvals, and submissions.
• Participate in audit preparation and regulatory inspections.
• Assist in preparing technical documents, SOPs, and compliance reports.
• Track submission timelines and ensure timely regulatory filings.
• Support new product registration and market expansion initiatives.
• Ensure confidentiality and accuracy of regulatory information.