Senior Regulatory Affairs Specialist

2 days ago

Bengaluru India Biocon Biologics Full time

Job Description

We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.

RESPONSIBILITIES:

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

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

Ensure and lead regulatory compliance for biosimilar products

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

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

KNOWLEDGE AND SKILLS

Comprehensive understanding of Regulatory activities

Experienced in analytical method development, method validation, method transfers and characterization of biologic products. Regulatory experience with product filings

Ability to understand and communicate scientific CMC information

Anticipate and prevent potential issues

Ability to communicate regulatory strategies and requirements to ensure expectations are understood

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