Job Title

Job Title: Drug Regulatory Affairs SpecialistLocation: Parwanoo, Himachal Pradesh(Bus Service Available from Panchkula, Pinjore, Kalka in HARYANA) Experience: 2-3 Years in Pharmaceutical IndustryJob Description: We are seeking a highly motivated Drug Regulatory Affairs Specialist to join our team. The ideal candidate will have 2-3 years of experience in the pharmaceutical industry with a strong understanding of regulatory requirements and dossier compilation. The role requires close collaboration with internal teams and external clients to ensure timely submission of regulatory documents.Key Responsibilities: Compile, review, and submit high-quality regulatory dossiers (e.g., CTD, ACTD) for new product registrations, renewals, and variations. Communicate effectively with international clients to deliver necessary documents and information for dossier preparation and submission. Coordinate with internal departments (e.g., R&D, QA/QC, Production) to gather technical documents required for regulatory submissions. Maintain and update regulatory databases, records, and documentation for ongoing projects. Monitor changes in regulatory guidelines and ensure adherence to current regulations. Support product registrations, renewals, and variations across different markets. Liaise with regulatory agencies and respond to their queries in a timely manner.Qualifications and Skills: Bachelor's degree in Pharmacy, Life Sciences, or a related field. A Master's degree is a plus. 2-3 years of experience in a Drug Regulatory Affairs role within the pharmaceutical industry. Expertise in dossier compilation (CTD, ACTD format). Strong knowledge of global regulatory requirements (FDA, WHO, etc.). Excellent communication skills to interact with clients and internal teams. Attention to detail and the ability to handle multiple projects simultaneously. Proficiency in Microsoft Office and regulatory submission software.Please submit your application here or email your resume to hr.unit2@ with the subject line "Regulatory."