Title:  Manager - 2

Page 1 of 2 JOB DESCRIPTION Job Title: Manager-IRA Job Grade: G11A Department: India Regulatory Affairs Sub-function: Corporate Relations Location: Tandalja Job Summary Regulatory submissions of drugs and medical devices in India. Area Of Responsibility • Evaluation of regulatory strategies for products to be registered in India. • Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI. • Evaluation and submission of applications on online portal for import registration/import license of drugs and medical devices in India. • Evaluation of the documents that need to be submitted with the applications and coordinating with the respective team for finalization. • Evaluation and submission of application for getting BE permission for export registration. • Evaluation and submission of application for getting permission to manufacture drugs for examination, test or analysis in Form CT-10/12/13. • Evaluation and submission of application for getting permission to import drugs for examination, test or analysis in Form-11/Form CT-17. • Evaluation and submission of application for getting permission to import drugs in Form 8. • Evaluation and submission of applications for getting permission to import medical devices for examination test and analysis in MD-16. • Reviewing Draft Gazette notification related to regulatory domain and sharing comments on the same. • Evaluation and submission of response to the market complaints raised by regulatory authority. Work Conditions: Physical Requirements: Travel Estimate Only if required Education and Job Qualification M. Pharm Experience Page 2 of 2 JOB DESCRIPTION 5- 10 years’ experience required in Regulatory Affairs for India Market. Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).