Regulatory Representative

3 weeks ago


Ahmedabad, Gujarat, India Vanshika Enterprises Full time

b Fluent in EnglishImmediate JoinerExperience Minimum 3 yearsThe Regulatory Representative is responsible for ensuring compliance with all relevant regulations and standards in the development manufacturing and marketing of the company s products This role involves preparing and submitting documentation for regulatory approvals monitoring regulatory changes and advising the company on regulatory strategies and requirements Key Responsibilities xc2 xb7 Prepare and submit regulatory documents to relevant authorities e g FDA EMA for product approvals renewals and variations xc2 xb7 Ensure all submissions comply with applicable regulations and guidelines xc2 xb7 Monitor and interpret regulatory requirements and ensure company compliance xc2 xb7 Maintain knowledge of current and future regulations guidelines and standards xc2 xb7 Conduct internal audits and assessments to ensure ongoing compliance xc2 xb7 Maintain and update regulatory documentation including technical files product labels and marketing materials xc2 xb7 Generate and review reports regulatory dossiers and other documentation as required xc2 xb7 Work closely with other departments including R D Quality Assurance Manufacturing and Marketing to provide regulatory guidance and support xc2 xb7 Participate in project teams to ensure regulatory requirements are integrated into product development plans xc2 xb7 Develop and implement regulatory strategies to facilitate product development and approval processes xc2 xb7 Advise on regulatory aspects of new product development and market entry xc2 xb7 Provide training to company staff on regulatory requirements and best practices xc2 xb7 Stay updated on industry trends and developments and disseminate relevant information within the organization xc2 xb7 Liaise with regulatory authorities and external consultants to ensure timely resolution of regulatory issues xc2 xb7 Represent the company at regulatory meetings industry conferences and seminars Job Types Full-time PermanentPay xe2 x82 xb950 000 00 - xe2 x82 xb960 000 00 per monthBenefits Provident FundSchedule Day shiftSupplemental pay types Yearly bonusExperience total work 5 years Preferred Work Location In person



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