EXECUTIVE - REGULATORY AFFAIRS (RA) @ M.J. BIOPHARM PVT. LTD.
M.J. Biopharm Pvt. Ltd. is seeking a dynamic Regulatory Affairs professional to join their team in Pune. The primary responsibilities include the preparation and review of CMC dossiers (CTD/eCTD – Module 3) and supporting regulatory submissions and responses to queries. The candidate will work closely with Analytical, QC, QA, and R&D teams for data compilation, ensuring strict compliance with ICH guidelines and global regulatory requirements. Additionally, the role involves reviewing analytical and characterization data for biologics while maintaining the highest standards of documentation and data integrity. Candidates should possess a strong background in biologics or sterile injectables with 3 to 5 years of relevant experience in Regulatory Affairs. Beyond technical expertise in ICH guidelines and pharmacopoeial standards like USP, EP, and IP, the role demands excellent communication skills to manage stakeholders effectively. Applicants are encouraged to provide their current CTC, expected CTC, and notice period when applying to this role in Maharashtra. High-quality dossier writing and review skills are essential for success in this position.