Biocon Hiring for Formulation Regulatory Affairs
Job Overview
- Position: Formulation Regulatory Affairs – US/Canada Market
- Company: Biocon
- Experience: 7–12 years
- Location: Bangalore
- Qualifications: M.Pharm / M.Sc in a relevant field
- Application Mode: Online (via email)
About Biocon
Biocon is a global leader in biopharmaceuticals, committed to delivering affordable and high-quality medicines worldwide. Renowned for its innovative research and development, Biocon focuses on transforming healthcare through cutting-edge technology and a patient-centric approach. Biocon Hiring for Formulation Regulatory Affairs
Key Responsibilities
Regulatory Submission
- Prepare, review, and submit ANDA/ANDS applications for the US and Canada markets.
- Manage the life cycle of filed products, ensuring compliance with regulatory updates.
Regulatory Knowledge
- Stay updated on the latest regulatory guidelines for the US and Canada markets.
- Collaborate with cross-functional teams (e.g., CMO/CDMO) during product development and manufacturing.
Documentation
- Review technical documentation related to product development and manufacturing.
- Publish regulatory dossiers in eCTD format, adhering to country-specific requirements.
Database Management
- Maintain and update regulatory databases to ensure compliance and streamline processes.
Qualifications and Skills
Education
- M.Pharm or M.Sc in a relevant field.
Experience
- 7–12 years in regulatory affairs within the pharmaceutical industry.
- Extensive experience in ANDA/ANDS filings and pre-approval activities for the US market.
- Strong knowledge of US regulatory guidelines and product life cycle management.
Preferred Candidate
- Stability in past roles within the pharmaceutical sector.
- Expertise in US submission processes and regulatory standards.
Why Join Biocon?
- Collaborative Environment: Work in a dynamic, team-driven setting.
- Global Impact: Contribute to high-impact projects in the global pharmaceutical market.
- Competitive Growth: Enjoy competitive compensation and professional development opportunities.
Application Process
To apply, email your CV to rashmi.gupta@biocon.com, including the following details:
- Total Experience
- Current CTC
- Number of ANDA/ANDS filings handled
- Pre-approval activities experience (Yes/No)
- Notice Period
- Willingness to relocate to Bengaluru (5-day working week)
Take the Next Step
Join Biocon and be part of a pioneering team shaping the future of biopharmaceuticals. Apply today to drive innovation and deliver impactful healthcare solutions globally! Biocon Hiring for Formulation Regulatory Affairs
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