BDR Pharmaceuticalsย 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:
โ Conduct technical reviews of regulatory documents for US market submissions.
โ Ensure compliance with FDA, ICH, and other international regulatory standards.
โ Collaborate with R&D, Manufacturing, and Quality teams for accurate documentation.
โ Support regulatory audits, inspections, and compliance initiatives.
โ Prepare and review ANDAs, DMFs, and other regulatory filings.
Preferred Skills:
- Strong understanding ofย US FDA regulations.
- Experience inย regulatory documentation & submissions.
- Knowledge ofย GMP, GLP, and ICH guidelines.
- Excellentย analytical and communication skills.
Eligibility & Qualifications
โ
Education: Bachelorโs/Masterโs in Pharmacy, Life Sciences, or related field.
โ
Experience: 2+ years in QA/QC/Regulatory Affairs (Pharma background preferred).
โ
Technical Skills: Proficiency in eCTD submissions, regulatory databases, and compliance tools.
Benefits & Perks
๐น Competitive salary + performance incentives
๐น Health insurance & wellness programs
๐น Professional growth in a global regulatory environment
๐น Work with industry-leading experts in pharma compliance
How to Apply
