Senior Executive - Regulatory Affairs

Senior Executive - Regulatory Affairs is responsible for managing regulatory documentation, licensing applications, certification processes, and compliance activities related to pharmaceutical manufacturing and export operations. The involves preparing and submitting regulatory applications, coordinating with regulatory authorities, maintaining compliance records, reviewing product artworks, and ensuring timely approvals as per regulatory requirements.

Roles & Responsibilities:

• Prepare and submit applications for COPP Certificates, WHO GMP, Non-WHO GMP, and State GMP certifications.
• Handle applications for FSC, MSC, MMC, Non-Conviction, Performance, and Capacity Certificates.
• Manage applications for additional product permissions for domestic and export markets.
• Coordinate manufacturing licence applications, renewals, and regulatory approvals.
• Prepare and submit applications for WHO GMP, GMP, GLP, and related regulatory certifications.
• Handle applications for wholesale licence fresh approvals and renewals.
• Coordinate loan licence applications, renewals, and test licence applications (Form 29) with FDCA authorities.
• Manage regulatory documentation related to CT forms, Dual NOC, Export NOC, and other statutory approvals.
• Handle ONDLS applications, IFP-related activities, and other regulatory submissions.
• Review product artworks, labels, packaging materials, and regulatory content for compliance.
• Coordinate with internal departments for collection and verification of regulatory documents.
• Maintain accurate records of regulatory submissions, approvals, certificates, and compliance documentation.
• Follow up with regulatory authorities and departments for timely approvals and licence processing.
• Ensure compliance with pharmaceutical regulations, GMP guidelines, and statutory requirements.
• Monitor regulatory timelines and maintain trackers for licence renewals and submissions.
• Support audits, inspections, and compliance reviews related to regulatory affairs.
• Coordinate with QA, QC, Production, Purchase, and Export departments for regulatory support activities.
• Stay updated with changes in pharmaceutical regulations, compliance requirements, and government guidelines.
• Prepare MIS reports, regulatory status reports, and compliance updates for management review.
• Maintain confidentiality and accuracy of regulatory data and documentation.

“The Care Continues” reflects the company’s commitment to creating a continuous chain of care that connects people and improves health outcomes worldwide.

Cadila Pharmaceuticals Ltd. is one of India’s largest privately held pharmaceutical companies. With over seven decades of experience, the company focuses on developing and manufacturing affordable, high-quality medicines for patients across the globe.

Driven by innovation and research, Cadila Pharma has made significant contributions to healthcare through its strong drug discovery and development capabilities.

Core Strengths

• Innovation-led drug discovery and development
• Strong investment in Research & Development (R&D)
• Commitment to affordable healthcare solutions
• Ethical clinical research and medical practices
• Global presence with impactful healthcare solutions

Vision

• To be a leading pharmaceutical company in India
• To become a significant global player
• To deliver high-quality, affordable, and innovative medical solutions

Mission

• Discover, develop, and market medicines to prevent, diagnose, and cure diseases
• Achieve customer satisfaction and global leadership in chosen markets
• Drive excellence through world-class R&D and technology
• Act as a responsible corporate citizen with high ethical standards

Work Culture & Employee Environment

Cadila Pharma fosters a supportive and growth-oriented workplace:

• Safe and eco-friendly work environment
• Modern facilities (transport, cafeteria, gym, guest house)
• Fast-track career growth opportunities
• Focus on employee health, happiness, and work-life balance

Employee Engagement & Development

• Regular cultural, sports, and social activities
• Continuous learning and growth opportunities
• Strong emphasis on employee well-being

Corporate Social Responsibility (CSR)

Through its CSR arm, the company actively contributes to society:

• Education initiatives like Back to School programs
• Cleanliness drives (Safai Abhiyan)
• Tree plantation campaigns
• Health awareness programs like AIDS Walkathons
• Encouraging employee volunteering

Commitment to Excellence

Cadila Pharma combines cutting-edge research with ethical business practices to deliver impactful healthcare solutions, aiming to improve lives and create a healthier world.