Require Senior Regulatory Affairs Associate at PAREXEL

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 : Senior Regulatory Affairs Associate

Job Description
Supported the CMC activities related to Small Molecules manufacturing and control including authoring of submission dossiers related to :
• Post Approval variations
• Understanding of EU/WHO/US regulations & guidance allowing appropriate review and compilation of data to appropriate standards & requirements
• Experienced in CTD update/authoring ( CTD Module 1, 2&3)
• Handled and responded Health Authorities Request
• US & CA Annual reports, Renewals, PQVAR, APR
• Assessment of the Change Controls and associated technical dossiers
• Excellent individual project management and communication skills
• Veeva tool experience

Candidate Profile
• Bachelors / Masters in Pharmacy OR Bachelors / Masters in any of Life
• 5/6 years of experience

Additional Information
Qualification : Bachelors/Master’s degree in Pharmacy, Life Sciences
Location : Bengaluru
Industry Type : Pharma / Healthcare / Clinical research
End Date : 20th September, 2023