Regulatory Affairs Executive / Senior Executive - LVP

Promea Therapeutics Pvt. Ltd.; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Promea Therapeutics Pvt. Ltd.

in Hyderabad is seeking a Regulatory Affairs Executive / Senior Executive - LVP to lead regulatory submissions for domestic and export markets, including CTD/eCTD/ACTD dossiers. You will prepare, compile, and maintain regulatory documentation, coordinate with R&D, QA, manufacturing, and packaging teams, respond to deficiency letters, and ensure GMP compliance and timely approvals.

Qualifications

• Prepare and submit regulatory dossiers for LVPs and sterile injectables.
• Handle CDSCO, State DCA, and international regulatory submissions.
• Maintain regulatory documentation for registrations, renewals, and variations.
• Coordinate with R&D, QA, QC, manufacturing, and packaging teams.
• Respond to deficiency letters and regulatory queries.

Responsibilities

• Prepare responses to agency queries and information requests.
• Ensure labeling, carton artwork, and prescribing information meet regs.
• Support product lifecycle management for domestic and export markets.
• Maintain submission trackers and regulatory databases.

Job description

Regulatory Affairs Executive / Senior Executive - LVP

Job ID - 1084

• 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.