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.

- Robust knowledge of global regulatory frameworks and dossier preparation.

- Proven track record of handling international submissions and approvals

.

Skills & Attributes

- Strategic regulatory planning and execution.

- Strong communication and negotiation skills with authorities.

- Ability to manage complex compliance requirements across geographies.

- Leadership in cross-functional collaboration and regulatory risk management.

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Interested candidates can share their profile at [email protected]

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