Regulatory Affairs – US Market Job Opening at BDR Pharmaceuticals

BDR Pharmaceuticals is a leading name in the pharmaceutical industry, specializing in innovative drug formulations and regulatory-compliant manufacturing. With a strong presence in domestic and international markets, BDR Pharma is known for its commitment to quality, compliance, and cutting-edge research.

Detailed Job Description

Job Title: Regulatory Affairs – US Market

Location: Vadodara (On-site)

Experience: QA/QC Professionals Transitioning to Regulatory Affairs

Key Responsibilities:

✔ Conduct technical reviews of regulatory documents for US market submissions.
✔ Ensure compliance with FDA, ICH, and other international regulatory standards.
✔ Collaborate with R&D, Manufacturing, and Quality teams for accurate documentation.
✔ Support regulatory audits, inspections, and compliance initiatives.
✔ Prepare and review ANDAs, DMFs, and other regulatory filings.

Preferred Skills:

• Strong understanding of US FDA regulations.
• Experience in regulatory documentation & submissions.
• Knowledge of GMP, GLP, and ICH guidelines.
• Excellent analytical and communication skills.

Eligibility & Qualifications

✅ Education: Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field.
✅ Experience: 2+ years in QA/QC/Regulatory Affairs (Pharma background preferred).
✅ Technical Skills: Proficiency in eCTD submissions, regulatory databases, and compliance tools.

Benefits & Perks

🔹 Competitive salary + performance incentives
🔹 Health insurance & wellness programs
🔹 Professional growth in a global regulatory environment
🔹 Work with industry-leading experts in pharma compliance

How to Apply

Application Link