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 Consultant
Job Description
• 6+ years of experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.
• Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
• Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
• 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.
• Strong communication and collaboration skills, ability to work independently.
Additional Information
Experience : 6+ years
Location : Bengaluru, Hyderabad, Mumbai
Job ID : R0000037359
Regulatory Affairs Consultant : Apply here
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Ph.D Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
