Regulatory Affairs Specialist – US Market (Formulation RA)

🔍 Job Opportunity: Regulatory Affairs Specialist – US Market (Formulation RA)
📍 Location: Bengaluru, Karnataka
🏢 Company: Biocon
🎓 Qualification: M. Pharma / M.Sc.
🕒 Experience Required: 7–10 years
💼 Job Level: Assistant Manager / Deputy Manager
🏢 Work Mode: On-site (5 Days Working)


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🧾 Role Overview:

Biocon is looking for a highly skilled Regulatory Affairs Specialist for the US Market, focusing on Formulation Regulatory Affairs. The role involves handling end-to-end regulatory processes including ANDA/ANDS preparation, submission, and lifecycle management.


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🛠️ Key Responsibilities:

Prepare, review, and submit ANDA/ANDS dossiers (including CTD modules) for the US market.

Manage lifecycle activities for products filed in the US.

Ensure compliance with current US FDA regulatory guidelines.

Provide regulatory inputs to cross-functional teams, including CMO and CDMO partners.

Maintain and update regulatory databases.

Publish dossiers in eCTD format per submission requirements.

Review technical documentation from R&D and manufacturing teams.



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✅ Required Skills:

Hands-on expertise in ANDA/ANDS filing

Sound knowledge of US submissions and FDA regulations

Experience in regulatory publishing and lifecycle management

Stable track record in a pharmaceutical company

Good communication and documentation skills



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📌 Important Candidate Info to Share with CV:

Total experience

Current CTC

Number of ANDA/ANDS filings handled

Experience with pre-approval activities

Notice period

Willingness to relocate to Bangalore (yes/no)



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📩 Apply here: Application link

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