Role Purpose To lead and manage regulatory strategy, submissions, and compliance for pharmaceutical and food products, ensuring timely approvals, lifecycle management, and adherence to global regulatory standards.

Key Responsibilities

- Develop and implement regulatory strategies for product development, formulation changes, and market approvals.
- Prepare and submit CTD/eCTD dossiers (IND, NDA, ANDA, MAA, variations, renewals).
- Manage DMF filings, updates, and coordination with regulatory authorities and partners.
- Ensure compliance with FDA, EMA, ICH, GMP, GCP/GLP for pharma and FSMA, FSSAI, HACCP, ISO22000 for food products.
- Act as the primary contact for regulatory authorities, handling queries, responses, and inspection readiness.
- Oversee global registrations, CPP/CoPP, import/export documentation, and food product certifications.
- Provide regulatory guidance to R&D;, QA, Manufacturing, Medical Affairs, and Commercial teams.
- Manage post-market surveillance, safety reports, variations, renewals, and compliance documentation.




- Conduct regulatory risk assessments and propose mitigation strategies.
- Facilitate internal audits and external inspections to ensure compliance.
- Maintain Regulatory Information Management Systems (RIMS) and documentation control.

Qualifications & Experience

- Post Graduation in Science / Engineering (Chemistry) / Pharmacy.
- 15–20 years of experience in Regulatory Affairs within the pharmaceutical/chemical industry.
- Strong knowledge of global regulatory frameworks and dossier preparation.
- Proven track record of handling international submissions and approvals.

Skills & Attributes

- Strategic regulatory planning and execution.
- Solid communication and negotiation skills with authorities.
- Ability to manage complex compliance requirements across geographies.
- Leadership in cross-functional collaboration and regulatory risk management.

? Interested candidates can share their profile at [email protected]

📌 Senior Manager Regulatory Affairs (Hyderabad)
🏢 Solentraaglobal
📍 Hyderabad