HYDERABAD · FULLTIME
Regulatory Affairs Executive / Sr Executive - LVP
Promea Therapeutics
Hyderabad · onsite · Posted 3d ago
Sourced from
Undisclosed1–4 yrsfulltimeHyderabad
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Section · 01
About this role
- 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 RD, 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.
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
Product Life Cycle ManagementDossierExportregulatory changesRegulatory AffairsEctdDossier PreparationauditsChange ControlCustomer AuditsQuality SystemsQuality AssuranceQuality ControlManufacturingcompliancePharmaceutical
Section · Company
About Promea Therapeutics
Promea Therapeutics
Medical Equipment
501
employees
2017
9 years old
Hyderabad/Secunderabad, Telangana
India
About
Promea Therapeutics is an innovative medical device manufacturing company specializing in Life Science products, Diagnostics.
Industries
Medical EquipmentBiotechnologyPharma
Employee ratings
225 reviews
4.1/ 5
Culture
3.9
Career growth
3.7
Work-life
4.0
Employees rate it well for
Senior Management31Learning28Work Culture26Work Environment24Team Members14
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