Biocon Biologics Hiring Manager Regulatory Affairs

Biocon Biologics Hiring Manager Regulatory Affairs

5 August, 2022

Biocon Biologics Hiring Manager Regulatory Affairs

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.

· Plan and Execute regulatory requirement for new and existing filings to ensure corporate goals are met

· Leads regulatory teams efforts for preparation and maintenance of risk assessment and mitigation strategy development

· Develop the filing strategy and budget for the department to achieve optimized key objectives

· Engaging with the agencies for discussion and negotiations on any outstanding regulatory issues and to expedite approvals

· Manages the content of the global regulatory dossiers and leads the regulatory product strategies across MoW markets

· Manages the content of the global regulatory dossiers and leads the regulatory product strategies across MoW markets

· Facilitate quick closure of internal and external outstanding regulatory issues

· Advices management for current guidance, regulations and standards

Regulatory Policy

· Working with national agencies to harmonize the guidance in line with global best practices

· Educate and influence external stakeholders to improve the uptake of biosimilars

Regulatory Support

Lead the actions / efforts and internal team (need basis) for streamlining regulatory systems and work with CFTs to streamline the processes involved

Regulatory Intelligence

Responsible for assessment of regulatory consultants and trade consortium Experience of 10 plus years in Regulatory Affairs’ across various geographies

· Comprehensive knowledge of the development process and experience in product registrations in markets

· Technical and managerial skills to understand and guide cross functional teams on process development, analytical development , process scale up , product characterizations, clinical and bioanalytical development.

· Experience and expertise to develop regulatory strategy from development stage to filing and approval.

· Experience in preparing change notifications and convincing partners/agencies inline with global expectations & due diligence in alliance management

Experience in working with regulatory consultants and regulatory team from partner companies in markets

Location: Bangalore

Work Experience: 8 to 15 years

Apply HERE

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