PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Regulatory Affairs Associate
• Around 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
• 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 with minimum supervision
Experience : 2-5 years
Qualification : B.Pharm or M.Pharm
Location : India - Any Region - Home Based
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th February, 2022
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