Senior Regulatory Affairs Specialist

7 days ago


New Delhi, India Classic Search Private Limited Full time

Role -Team Lead - International Regulatory Affairs Location - Bangalore Industry - Pharmaceutical Required Experience :- 10-15 years Education :- M.Pharma / M.ScMust have experience in IRA handling regulated or unregulated region and submissions, handling a team of 2 for submission Will lead a team of atleast 10 people(Team Leading exp is mandatory) Good understanding experience in handling regulated markets. Evaluation andRegulatory Impact Assessment of Change Controls and Deviations. Understanding and awareness of regulated markets region Pharma regulations with country specific requirements, checklists guideline on latest regulations Ability to contribute to Plan and execute Dossier Compilation Ensure timely Review and Submission to Health Authorities of assigned regulated markets Planning and Submission of Amendments / Supplements Timely submission of Responses to the Queries received from various Regulatory Authorities. Oversees country compilation, quality review and submissionof country specific applications Develop and maintain relationships regulated markets team in alignment with allotted projectsApplicants with relevant experience can email their resumes to poornima.c@classicsearchplc.com



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