BIOCON HIRING IN REGULATORY AFFAIRS – B PHARM/M PHARM, B TECH/M TECH BIOTECH, BSC/MSC CAN APPLY

BIOCON HIRING IN REGULATORY AFFAIRS – B PHARM/M PHARM, B TECH/M TECH BIOTECH, BSC/MSC CAN APPLY
BIOCON HIRING IN REGULATORY AFFAIRS – B PHARM/M PHARM, B TECH/M TECH BIOTECH, BSC/MSC CAN APPLY
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Job Title: Manager – Global Regulatory Affairs

Location: Head Office, Bangalore, India

Company: Biocon Biologics

About Biocon Biologics:
Biocon Biologics is a leader in the biosimilars revolution, dedicated to providing high-quality, affordable healthcare globally. We aim to impact a billion lives with innovative, patient-centric solutions. Our multicultural environment fosters collaboration with partners and patients to achieve our mission.

Job Summary:
The Manager of Global Regulatory Affairs will develop and execute CMC regulatory strategies, manage marketing applications, and oversee lifecycle management for biosimilar products. This role requires collaboration across cross-functional teams and partners, ensuring compliance with regulatory requirements throughout product development and lifecycle.

Key Responsibilities:

ResponsibilitiesDescription
Develop and implement regulatory strategiesFor global registrations of biosimilar products.
Coordinate cross-functional activitiesSupport product development, approval, and long-term planning.
Collaborate with partnersExecute global regulatory activities.
Manage development of regulatory documentsIncluding briefing documents, CTAs, IND/IMPD, MAA/BLA, and responses to regulatory questions.
Provide regulatory directionOn global requirements to support product development.
Ensure regulatory filings consistencyMaintain per regulatory requirements throughout product lifecycle.
Support clinical/non-clinical strategiesDevelopment and execution.
Review and advise on CMC documentsStudy concept documents, protocols, and reports.
Collaborate with partners and affiliatesEnsure effective implementation of global regulatory strategies and plans.
Develop risk management and contingency plansParticipate in the process.
Lead regulatory complianceEnsure for biosimilar products.
Participate in regulatory meetingsEngage with Health Authorities.

Knowledge and Skills:

  • Comprehensive understanding of regulatory activities and product filings.
  • Strong team collaboration skills.
  • Familiarity with project management.
  • Ability to understand and communicate scientific CMC information.
  • Proactive in anticipating and preventing potential issues.
  • Strong communication skills for articulating regulatory strategies and requirements.
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Education/Qualifications:

  • Required: B Pharm/M Pharm, B Tech/M Tech Biotech, BSc/MSc.
  • Experience: Minimum 5 years in global regulatory affairs, preferably in advanced markets.

Meta Description:
Apply for the Manager of Global Regulatory Affairs at Biocon Biologics in Bangalore. B Pharm/M Pharm, B Tech/M Tech Biotech, BSc/MSc required.

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