Hiring Alert! The Global Regulatory Affairs organization is seeking professionals at all levels who have the attitude and skills to get it Right the First Time!
At Biocon Biologics, the Global Regulatory Affairs (GRA) consists of talented individuals who interface between the company and the regulatory agencies across the globe. The GRA group plays a vital role in carving robust regulatory strategy built on a strong scientific, technical and regulatory framework. The GRA team enables the organization with approvals from drug regulatory agencies from the USA (US-FDA), European Union (EMA), Australia (TGA), Canada (Health Canada), Japan (PMDA); and countries from Middle East (S. Arabia, Jordan, Turkey); Pan-American (Brazil, Mexico, Argentina), South Asian (S. Korea, Taiwan, Malaysia), Russian Federation (Russia, Ukraine), African (S. Africa, Algeria) regions, which have unique country-specific submission/review procedures for approval of drugs including biologics/biosimilars.
Skill sets required:
Good understanding and hands-on experience in Biologics, Drug Delivery, Medical Devices
Products filing & Dossier Submission experience in the US, EU and Most of World Markets
Complete understanding of Regulatory Life Cycle Management Practices
Excellent Communication skills – written and oral