Senior Regulatory Affairs Expert

16 hours ago

Bengaluru, Karnataka, India beBeeExpert Full time ₹ 1,20,00,000 - ₹ 2,50,00,000
Regulatory Affairs Specialist

We are seeking a skilled professional to lead our regulatory efforts. In this role, you will be responsible for developing and implementing regulatory strategies to support product development.

Key Responsibilities:
  • Plan and manage the 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 Biosimilars function.
Required Skills and Qualifications:
  • 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.
Benefits:

This role offers a unique opportunity to work on cutting-edge regulatory projects and develop your skills in a dynamic environment.

Others:

Please note that we are an equal opportunities employer and welcome applications from candidates with diverse backgrounds.

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