Biocon, a global leader in biopharmaceuticals, is seeking talented professionals for the Formulation Regulatory Affairs Role in the US/Canada Market. If you have the expertise and experience in regulatory submissions, this is an excellent opportunity to join a pioneering organization.
About the Role
The role involves end-to-end regulatory affairs management for formulations targeting the US and Canada markets. It requires expertise in preparing and submitting Abbreviated New Drug Applications (ANDA) and maintaining compliance with current regulatory guidelines.
Responsibilities
- Regulatory Submission:
- Prepare, review, and submit ANDA/ANDS applications, including all modules, to the US regulatory authorities.
- Handle life cycle management for filed products.
- Regulatory Knowledge:
- Stay updated on the latest regulatory guidelines and requirements for the US market.
- Provide regulatory inputs to cross-functional teams (e.g., CMO/CDMO projects) during product development and manufacturing.
- Documentation:
- Review technical documentation, including developmental and plant-related data, required for dossier submission.
- Publish regulatory dossiers in eCTD format as per country-specific requirements.
- Database Management:
- Maintain regulatory databases, ensuring timely updates.
Qualifications and Skills
- Education:
- M.Pharm or M.Sc in a relevant field.
- Experience:
- 7-12 years in regulatory affairs within the pharmaceutical industry.
- Hands-on experience in ANDA/ANDS filings and pre-approval activities for the US market.
- Familiarity with regulatory guidelines and life cycle management of products.
- Preferred Candidate:
- Stability in past roles within the pharmaceutical sector.
- Knowledge of US submission processes and regulatory standards.
Why Join Biocon?
Biocon offers:
- A dynamic and collaborative work environment.
- Opportunities to work on high-impact projects in the global pharmaceutical market.
- Competitive compensation and growth potential.
Application Process
To apply, email your CV to rashmi.gupta@biocon.com with 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)
