Regulatory Affaris Associate

Parexel International Corporation

Bengaluru, Karnataka, India

Minimum 2 to 5 relevant experience in authoring standard operating procedures for various types of regulatory submissions including initial submissions, product post approval compliance activities and other license maintenance activities Should be able to interface between global regulatory and regional regulatory teams Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage Experience in handling CMC related health authority queries Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries. Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable Strong communications skills Ability to work independently or with minimum supervision QualificationsBPharma, MPharma or any Life science related qualification

2021-06-01 00:05:18

Apply to this job