Senior Officer - Regulatory Affairs

The Senior Officer – Regulatory Affairs will be responsible for preparing, reviewing, and submitting regulatory dossiers for pharmaceutical products across various markets. The involves ensuring compliance with country-specific regulations, supporting lifecycle management, and coordinating with cross-functional teams to facilitate timely approvals. The candidate will also handle technical documentation review, eCTD publishing, and regulatory query resolution while maintaining high standards of quality and compliance.

Roles and Responsibilities:

• Prepare, compile, and submit regulatory dossiers for formulations and drug products in target markets.
• Manage end-to-end dossier filing activities to ensure timely product approvals.
• Develop and maintain regulatory checklists as per country-specific guidelines.
• Conduct first-level review of technical documents including stability data, TTD, and PDR.
• Review analytical method validations and related documentation.
• Evaluate BMR, BPR, process validation reports, and hold time studies.
• Review specifications for API, semi-finished, and finished products.
• Perform initial review of product artwork and labeling to ensure regulatory compliance.
• Analyze change controls and assess regulatory impact for various markets.
• Evaluate vendor change notifications and determine compliance requirements.
• Support lifecycle management activities including post-approval changes and amendments.
• Prepare and submit variations, supplements, and annual reports as required.
• Manage compilation and publishing of eCTD dossiers and DMFs.
• Ensure proper formatting and submission of documents to regulatory authorities and clients.
• Assist in resolving regulatory queries from health authorities and customers.
• Review technical responses before escalation to senior management.
• Prepare and submit documents for facility registrations including USFDA filings.
• Coordinate with cross-functional teams such as QA, QC, Production, and R&D.
• Ensure adherence to regulatory guidelines, data integrity, and quality standards.
• Maintain proper documentation and records for audits and inspections.
• Monitor updates in global regulatory requirements and implement necessary changes.
• Support internal and external audits by providing required regulatory documentation.
• Contribute to continuous improvement in regulatory processes and systems.
• Ensure timely communication with stakeholders regarding regulatory updates and submissions.

USV Private Limited is an Indian pharmaceutical company dedicated to delivering high-quality medicines and healthcare solutions. With a strong focus on innovation, research, and patient care, the company serves both domestic and global markets.

Our Story

USV began its journey with a vision to provide reliable and effective healthcare solutions. Over the years, the company has grown into a well-established pharmaceutical organization known for its commitment to quality and innovation.

Through continuous investment in research and development, USV has strengthened its capabilities in delivering advanced formulations and improving patient outcomes.

Our Mission

• To provide high-quality and affordable healthcare solutions
• To enhance patient outcomes through innovation and research
• To maintain excellence in pharmaceutical manufacturing
• To build long-term trust with healthcare professionals and patients

Our Vision

To be a trusted global pharmaceutical company recognized for quality, innovation, and patient-centric healthcare solutions.

Our Services / What We Offer

USV Private Limited offers a wide range of pharmaceutical solutions, including:

• Development and manufacturing of pharmaceutical formulations
• Research-driven healthcare products
• Solutions across multiple therapeutic segments
• Global distribution of medicines

Why Choose Us

• Strong focus on research and innovation
• Commitment to quality and compliance
• Trusted presence in domestic and international markets
• Patient-centric approach to healthcare
• Continuous improvement in products and processes

Our Team

USV is supported by a team of experienced professionals, scientists, and healthcare experts who are dedicated to delivering high-quality pharmaceutical solutions and advancing medical science.

Infrastructure / Technology

The company operates advanced manufacturing and research facilities designed to meet global quality standards. Its infrastructure supports innovation, efficiency, and consistent product quality.

Our Commitment

USV Private Limited is committed to improving healthcare by delivering safe, effective, and affordable medicines. The company emphasizes ethical practices, innovation, and quality in all aspects of its operations.