Senior Regulatory Affairs Specialist

Role - Team Lead - International Regulatory Affairs

Location - Bangalore

Industry - Pharmaceutical

Required Experience : - 10-15 years

Education : - M.Pharma / M.Sc

Must 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 and Regulatory 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 submission of country specific applications
• Develop and maintain relationships regulated markets team in alignment with allotted projects

Applicants with relevant experience can email their resumes to poornima.c@classicsearchplc.com