PPIC - Executive
PROMEA THERAPEUTICS PRIVATE LIMITED
Regulatory Affairs Executive / Senior Executive - LVP
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 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.
Frequently Asked Questions
Is the salary disclosed for the Regulatory Affairs Executive / Senior Executive - LVP position at PROMEA THERAPEUTICS PRIVATE LIMITED?
The salary for this Regulatory Affairs Executive / Senior Executive - LVP role at PROMEA THERAPEUTICS PRIVATE LIMITED is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Executive / Senior Executive - LVP position at PROMEA THERAPEUTICS PRIVATE LIMITED located?
This Regulatory Affairs Executive / Senior Executive - LVP role at PROMEA THERAPEUTICS PRIVATE LIMITED is based in Hyderabad. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs Executive / Senior Executive - LVP role at PROMEA THERAPEUTICS PRIVATE LIMITED full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Regulatory Affairs Executive / Senior Executive - LVP role at PROMEA THERAPEUTICS PRIVATE LIMITED.
How do I apply for the Regulatory Affairs Executive / Senior Executive - LVP position at PROMEA THERAPEUTICS PRIVATE LIMITED?
Click the "Apply Now" button on this page. You will be redirected to PROMEA THERAPEUTICS PRIVATE LIMITED's official application portal hosted on greythr where you can submit your application directly.
When was the Regulatory Affairs Executive / Senior Executive - LVP job at PROMEA THERAPEUTICS PRIVATE LIMITED posted?
This Regulatory Affairs Executive / Senior Executive - LVP position at PROMEA THERAPEUTICS PRIVATE LIMITED was posted on Jul 8, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Executive / Senior Executive - LVP
PROMEA THERAPEUTICS PRIVATE LIMITED
You'll be redirected to PROMEA THERAPEUTICS PRIVATE LIMITED's official application page on greythr.