Regulatory Affairs Executive / Senior Executive - LVP

Promea Therapeutics; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Promea Therapeutics in India is seeking a Regulatory Affairs professional to manage dossiers, submissions, labels, and lifecycle activities for domestic and export markets. This role ensures compliance with CDSCO, State DCA, and international portals, coordinating cross‑functional teams to gather required documentation.

The candidate will handle deficiency responses, maintain regulatory databases, and support inspections and audits, while ensuring timely approvals and ongoing regulatory

Responsibilities

• Prepare, review, compile, and submit regulatory dossiers for pharmaceutical products including LVPs and sterile injectables for domestic and export ROW markets.
• Handle regulatory submissions through CDSCO, State DCA, and international portals per regulatory requirements.
• Manage regulatory submissions and correspondence to ensure timely approvals; lifecycle management of CTD/eCTD/ACTD dossiers.
• Prepare, compile, and maintain regulatory and technical docs for test licenses, registrations, renewals, variations, and licenses.
• Coordinate with R&D, QA, QC, Manufacturing, Validation, Packaging Development, and Supply Chain for regulatory documentation.
• Prepare and review product labels, carton artwork, inserts, prescribing information, and labeling to ensure compliance.
• Support new product registrations and lifecycle management for domestic and export markets.
• Prepare responses to deficiency letters, agency queries, and requests for additional information.
• Ensure compliance with regulatory guidelines, GMP, and quality systems.
• Review regulatory changes and assess impact on products and submissions.
• Maintain regulatory databases, submission trackers, approvals, licenses, and product registrations.
• Support regulatory inspections and GMP audits with required documentation.
• Participate in change control evaluations and assess regulatory impact for changes.
• Coordinate with international distributors, partners, and consultants for export registrations and compliance.
• Ensure timely renewal of manufacturing licenses, product registrations, Free Sale Certificates, COPP, and other approvals.

Job description

Responsibilities

• Prepare, review, compile, and submit regulatory dossiers for pharmaceutical products, including LVPs, sterile injectables, for domestic and export ROW markets.
• Handle regulatory submissions through CDSCO, State DCA, and international regulatory portals in accordance with applicable regulatory requirements.
• Handle regulatory submissions and hands‑on experience through the CDSCO and State DCA online portals, and manage all regulatory correspondence to ensure timely submission, effective follow‑up, and receipt of required approvals and experience in CTD/eCTD/ACTD dossier preparation and lifecycle management.
• Prepare, compile, and maintain regulatory and technical documentation required for test license, product registrations, renewals, variations, amendments, site registrations, manufacturing licenses, and post‑approval changes.
• Coordinate with cross‑functional teams, including R&D, Quality Assurance, Quality Control, Manufacturing, Production, Validation, Engineering, Packaging Development, and Supply Chain, to obtain and maintain documentation required for regulatory submissions.
• Prepare and review product labels, carton artwork, package inserts, prescribing information, and other labeling documents to ensure regulatory compliance.
• Support new product registrations and product lifecycle management activities for domestic and export markets.
• Prepare responses to regulatory deficiency letters, agency queries, and requests for additional information.
• Ensure compliance with applicable regulatory guidelines, GMP requirements, and company quality systems.
• Review regulatory changes and assess their impact on existing products and ongoing regulatory submissions.
• Maintain regulatory databases, submission trackers, approvals, licenses, and product registrations.
• Support regulatory inspections, GMP audits, and customer audits by providing required regulatory documentation.
• Participate in change control evaluations and assess regulatory impact for manufacturing, formulation, packaging, and process changes.
• Coordinate with international distributors, business partners, and regulatory consultants for export registrations and regulatory compliance.
• Ensure timely renewal of manufacturing licenses, product registrations, Free Sale Certificates, COPP, and other regulatory approvals as applicable.