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