REGULATORY EXECUTIVE @ SANGHARSH
Sangharsh is expanding its pharmaceutical team and is looking for a highly skilled Regulatory Executive with strong expertise in international markets, specifically focused on the Nigeria market. The successful candidate will be responsible for the preparation, compilation, and submission of CTD and ACTD dossiers to ensure products meet the specific regulatory requirements of Nigeria and other ROW regions. This role involves managing the entire product lifecycle and coordinating with internal teams to meet strict submission deadlines.
We require a professional with at least 5 years of experience in Regulatory Affairs who can handle and respond to regulatory queries and deficiencies accurately. Candidates should be proficient in using Microsoft Office, Adobe PDF tools, and AI-driven documentation tools. An M.Pharm degree is mandatory for this role. While the primary market focus includes Nigeria, the candidate will be part of a global team handling various international markets. Immediate joiners are preferred for this rewarding opportunity in the pharmaceutical sector.
We require a professional with at least 5 years of experience in Regulatory Affairs who can handle and respond to regulatory queries and deficiencies accurately. Candidates should be proficient in using Microsoft Office, Adobe PDF tools, and AI-driven documentation tools. An M.Pharm degree is mandatory for this role. While the primary market focus includes Nigeria, the candidate will be part of a global team handling various international markets. Immediate joiners are preferred for this rewarding opportunity in the pharmaceutical sector.
Key Requirements
Minimum 5 Years of experience in Regulatory Affairs within the Pharmaceutical industry.
Educational qualification of Master of Pharmacy (M.Pharm) is required.
Strong expertise in the preparation, compilation, and submission of CTD/ACTD dossiers.
Proven experience in lifecycle management of products across multiple global markets.
Ability to handle and respond effectively to regulatory queries and deficiencies.
Excellent coordination skills with cross-functional teams to ensure timely submissions.
Comprehensive understanding of regulatory guidelines for ROW (Rest of World) markets.
Hands-on experience with Microsoft Office tools for professional documentation.
Proficiency in using Adobe PDF tools for dossier compilation and editing.
Familiarity with AI tools for documentation and modern task management platforms.