International Regulatory Affairs (IRA) - Executive

The Executive – International Regulatory Affairs will be responsible for handling regulatory submissions, documentation, and compliance for various international markets. The involves coordinating with cross-functional teams such as R&D, QA, QC, and production to ensure timely and accurate dossier preparation and submission. The candidate will also track regulatory updates and ensure compliance with evolving global standards.

Roles and Responsibilities:

• Prepare and compile regulatory dossiers (CTD/eCTD/ACTD) for international submissions.
• Handle product registration processes in semi-regulated and regulated markets.
• Coordinate with internal departments for data collection and documentation.
• Review technical documents, specifications, and reports for regulatory compliance.
• Ensure timely submission of applications, variations, and renewals.
• Track submission status and respond to regulatory queries and deficiencies.
• Maintain regulatory databases and document management systems.
• Ensure compliance with international regulatory guidelines and requirements.
• Support product lifecycle management activities including variations and amendments.
• Monitor global regulatory changes and update internal processes accordingly.
• Coordinate with regulatory authorities, agents, and partners across countries.
• Ensure accuracy and completeness of all regulatory documentation.
• Participate in audits and ensure readiness for regulatory inspections.
• Maintain proper filing, archiving, and version control of regulatory documents.
• Assist in development of SOPs and continuous improvement of regulatory processes.

BioMatrix Healthcare Pvt. Ltd. is a pharmaceutical company engaged in the development, manufacturing, and global distribution of high-quality medicines. The organization focuses on delivering affordable and effective healthcare solutions while maintaining strong quality and regulatory standards.

Our Story

BioMatrix Healthcare Pvt. Ltd. was established with the vision of becoming a reliable global pharmaceutical partner. Over the years, the company has expanded its footprint across international markets, building long-term relationships with clients through consistent quality and service.

With a focus on innovation and operational excellence, BioMatrix continues to strengthen its presence in regulated and semi-regulated markets worldwide.

Our Mission

• To deliver high-quality and affordable pharmaceutical products
• To maintain strong compliance with global regulatory standards
• To build long-term partnerships with clients across the globe
• To continuously improve processes through innovation and expertise

Our Vision

To become a globally recognized pharmaceutical company known for quality, trust, and excellence in healthcare solutions.

Our Services / What We Offer

BioMatrix Healthcare Pvt. Ltd. offers a wide range of pharmaceutical services:

• Manufacturing of finished dosage formulations
• Global export of pharmaceutical products
• Contract manufacturing solutions
• Development of a diverse portfolio of therapeutic products

Why Choose Us

• Strong global presence in multiple international markets
• Focus on quality, compliance, and affordability
• Expertise in pharmaceutical manufacturing and exports
• Commitment to long-term partnerships
• Continuous improvement through innovation

Our Team

BioMatrix Healthcare is supported by a team of experienced professionals dedicated to ensuring product quality, regulatory compliance, and customer satisfaction. The team works collaboratively to meet global healthcare needs.

Infrastructure / Technology

The company operates with advanced manufacturing facilities and systems designed to meet international quality standards. Its infrastructure supports efficient production, quality assurance, and timely delivery of pharmaceutical products.

Our Commitment

BioMatrix Healthcare Pvt. Ltd. is committed to improving global healthcare by delivering safe, effective, and affordable medicines. The company emphasizes quality, innovation, and ethical practices in every aspect of its operations.