Arch Recruiting Solutions
Website:
archrecruitingsolutions.com
Job details:
Hiring: Officer – Regulatory Affairs (RA) | Immediate Joiners Preferred
** Mumbai based candidates preferred**
Location: Lower Parel, Mumbai
Experience: 4–5 Years
Joining: Immediate Joiners Only
Interview - F2F only
We are looking for an experienced Regulatory Affairs Officer with strong exposure to international markets and dossier management.
🔹 Key Skills:
• CTD/ACTD Dossier Compilation & Review
• CMC Documentation & Technical Review
• MOH Queries Handling
• Variations & Renewals
• Change Control & Artwork Checking
• Regulatory Exposure to LATAM, GCC, MENA, SEA & Africa Markets
🔹 Responsibilities:
• Prepare and review country-specific, CTD and ACTD dossiers for new submissions, renewals and variations.
• Author and compile CTD sections (M1, M2, M3, M4 & M5).
• Review technical documents including PVP, PVR, AMV, Stability Reports, Specifications, COAs, BE Studies, DMFs, etc.
• Coordinate with manufacturing plants for regulatory documents, samples and supporting data.
• Ensure accuracy and compliance in all regulatory documentation and submissions.
• Possess thorough knowledge of ASEAN, Africa, LATAM, GCC and MENA regulatory requirements.
Strong individual contributor with excellent teamwork and communication skills.
Candidates who can join immediately only apply
Click on Apply to know more.