Biocon Biologics Limited hiring for Manager – Global Regulatory Affairs
Manager – Global Regulatory Affairs
Bangalore, India
Job Summary:
Accountable for global CMC regulatory strategies with focus on analytical aspects for developmental/marketing submissions and Life Cycle Management for biosimilar products.
Role & 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 cycleSupport 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 functio
- Ability to communicate regulatory strategies and requirements to ensure expectations are understood• Team skills, especially in working with internal and external partners
- Familiarity with project management requirements
Knowledge and Skills
- Comprehensive understanding of regulatory activities
- In depth knowledge of analytical aspects of biosimilar development, protein characterization and analytical testing
- Hands on experience of method development, qualification/validation, sample analysis
- Ability to give critical inputs on study design for process change, method change, stability studies, bridging studies, outsourced studies etc as per relevant ICH guidelines
- Ability to understand and communicate scientific CMC information
- Anticipate and prevent potential issues
Preferred candidate profile
- Prior experience in analytical and characterization is a must.
- A min of 8/9 years of experience in analytical/characterization span.
- Preference for those who started with analytical/characterization and later moved to regulatory affairs.
Pls note that analytical & characterization experience is mandatory; hence, folks do not have this background don’t apply. Experienced folks pls email the updated resume to [email protected] .
