Opportunities in Global Regulatory Affairs

1 month ago

Bengaluru, India Biocon Biologics Full time

Biocon Biologics is a fully-integrated ‘pure play’ biosimilars organisation globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.


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.


Responsible for:

• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio

• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products

• Collaboration with partners to develop and execute global regulatory activities

  • DMF preparations, review of changes and routine updates to Global Regulatory Agencies
  • Dossier preparations of Biosimilar biologics for ICH regions



Key Activities:

Regulatory Strategy and Execution

• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements

• Provide regulatory direction on global regulatory requirements to support product development

• Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle

• Support development and execution of clinical/non-clinical strategies

• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration

• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans

• With minimal supervision, participate in development of risk management and contingency planning

• Ensure and lead regulatory compliance for biosimilar products

• Participation in regulatory meetings with Health Authorities


Regulatory Intelligence:

• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products

• Review and assess impact of regulatory decisions for competitive products

• Generate and communicate biosimilar intelligence


Collaboration:

• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products

• Identify process needs to meet internal challenges

• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function


Knowledge and Skills

• Comprehensive understanding of Regulatory activities

• Regulatory experience with product filings

• Team skills, especially in working with internal and external partners

• Familiarity with project management requirements

• Ability to understand and communicate scientific CMC information

• Anticipate and prevent potential issues

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