Regulatory Affairs Manager Jobs in Coimbatore Pharmaceutical Company

📋 Job Description

Jobzi is sourcing qualified candidates for Regulatory Affairs Manager positions in Coimbatore's private Pharmaceutical Company sector. This is a full-time opportunity with a reputed Pharmaceutical and Life Sciences employer in Coimbatore offering competitive salary, structured growth, and a professional work environment. Tamil communication skills are preferred alongside English for professional and business interaction in Coimbatore.

📌 Key Responsibilities

• Lead and manage a team of regulatory affairs executives for multi-market product registration activities
• Develop global regulatory strategy for new product launches, lifecycle management, and line extensions
• Prepare and review CTD dossiers for USFDA ANDA/NDA, EU MA, and CDSCO submissions
• Interface directly with FDA, EMA, and CDSCO for regulatory queries, responses, and meetings
• Manage regulatory timelines, milestone tracking, and resource planning for registration projects
• Monitor global regulatory intelligence and assess impact of new guidelines on product portfolio
• Mentor junior RA team members and contribute to regulatory training programs

🎓 Qualifications and Requirements

• M.Pharm or M.Sc in Pharmaceutical Sciences with 7-14 years of regulatory affairs experience
• Minimum 2 years in a regulatory affairs leadership or team lead role
• Deep expertise in CTD (eCTD) preparation for USFDA, EU, and emerging markets
• RAPS RAC certification (USA, EU, or Global) strongly preferred
• Hands-on experience with eCTD compilation tools (Lorenz docuBridge, IDMP tools, or similar)
• Thorough understanding of FDA 21 CFR Part 314, EU Directive 2001/83/EC, and CDSCO guidelines
• Excellent project management and cross-functional coordination skills
• Good Tamil and English communication skills for team coordination and client interaction in Coimbatore.

✅ Required Skills

🏆 Certifications and Qualifications

B.Pharm, M.Pharm, M.Sc Life Sciences, MBBS, BDS, Ph.D. in Pharmaceutical Sciences, ICH GCP certification, Drug Safety certification (ISoP), CCRP (Clinical Research), RAPS certification (Regulatory Affairs)