Regulatory Affairs Executive Molkem Chemicals

2.0 - 5.0 years

3 - 6 Lacs

ahmedabad

Work from Office

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.

Posted 3 days ago

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