Global Regulatory Affairs

The Global Regulatory Affairs (GRA) at Biocon consists pool of talented individuals who are the interface between the company and the regulatory agencies across the globe. Within the company, GRA group plays vital role in carving robust regulatory strategy built on strong scientific, technical and regulatory framework. The GRA group embraces individuals with hands on experience on process and product development; analytical sciences; quality management systems; regulatory writing and procedures, leading to successful global submissions and approvals.

Understanding the guidelines, regulations and regulatory processes of each country is challenging especially for complex molecules with dynamic and evolving regulatory landscape. 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 have unique country specific submission/review procedures for approval of drugs including biologics/biosimilars.

Robust regulatory competency coupled with focused team effort resulted in us being the "first to file and approval" of a biosimilar Trastuzumab with the US FDA followed by its approval EMA, TGA and Health Canada. Our biosimilar applications for biosimilar peg-filgrastim, insulin glargine, insulin aspart and bevacizumab are also approved/under review across globe including US FDA, EMA, TGA, MedSafe, PMDA and Health Canada. Currently, GRA team at Biocon is working on rich pipeline of biosimilars comprising both partnered and in-house projects spanning therapeutic areas of oncology, immunology, metabolic disorders and general medicines.

Strategy

Responsible for sharing with the packaging team country specific requirements for development of artworks for emerging markets

Submissions

Review coordinate and track internal approval of artworks are received based on business requirement related to registrations/ renewals/ Variations

Regulatory Support

Responsible for discussing with the partners in emerging market countries and coordinate internally on finalization and submission of AWs.

Regulatory intelligence

Responsible for gathering and maintenance of country specific regulatory intelligence respective to artwork requirements

Regulatory compliance

Responsible for ensuring that the AW's are in line with the country specific requirements and CCDS.

Regulatory compliance

Preparation and maintenance of artwork database / country

Regulatory compliance

Preparation and maintenance of regulatory SOP for management of artworks

Team management

Recruitment, training and development of artwork team

Work experiance - 8 years to 15 years

Location - Bangalore
Bengaluru Karnataka India

Salary Criteria