Regulatory Affairs Executive

Position- Executive/Sr. Executive

Dept.-Regulatory Affairs

Key Responsibilities

• Act as the first point of support for Business Development Managers on product-related queries from India.
• Coordinate and organize audits of supplier production facilities to ensure compliance with international standards.
• Gain exposure to and support during international regulatory audits (USFDA, WHO, ANVISA, EDQM).
• Understand and translate client quality parameters for raw materials, ensuring supplier adherence.
• Monitor supplier manufacturing processes for compliance with national and global standards.
• Assist in preparing and managing documentation for specification setting, change controls, regulatory submissions, annual product reviews, and investigations with suppliers.
• Maintain up-to-date knowledge of regulatory requirements across different zones and international guidelines.
• Support clients during factory audits and commercial visits to supplier facilities.
• Collaborate with cross-functional teams to aid organizational growth and business development.
• Ensure timely completion of regulatory submissions and strict adherence to quality standards.
• Represent the organization at national and international exhibitions.
• Participate in continuous training programs to upgrade skills and regulatory knowledge.

Qualifications & Skills

• Bachelors or Masters degree in Pharmacy, Life Sciences, or a related field.
• 25 years of experience in Regulatory Affairs, Quality Assurance, or Compliance (pharmaceutical/chemical industry preferred).
• Strong understanding of international regulatory guidelines (USFDA, WHO, ANVISA, EDQM).
• Experience in supplier audits and compliance monitoring.
• Excellent communication, coordination, and stakeholder management skills.
• Strong attention to detail and ability to work under strict timelines.
• Willingness to travel for audits, client visits, and international exhibitions.