Regulatory Associate - Medical Writing

As an experienced medical writer, your role will involve writing high-quality CTD modules including nonclinical and clinical overviews & summaries such as Module 2.5, 2.4, 2.7 as per the EU submission requirements. You will also be responsible for responding to clinical deficiencies, assisting in drug development strategy, updating SmPC, Patient information leaflet, CCDS, Safety variations, preparing clinical study reports, study design, and synopsis. Additionally, you will play a key role in the clinical development strategy, review of study reports, published papers, literature search, and regulatory evaluation. Your expertise will be crucial in Rx to OTC evaluation, PSURs, PADER, and RMP. Qualifications required for this role include: - MBBS in Medicine/ M.Pharma in Pharmacy/ Medical-MS/MD in Pharmacology/ Ph.D/Doctorate in Pharmacy - Experience in Medical writing for regulatory submissions in Europe - Knowledge and experience in Non-clinical overview, Clinical overview, PSUR, EU submission, Clinical Pharmacology, Module 2.5, Scientific Writing ICH, Regulatory Submissions, Medicine, DCP, CTD, Clinical Research, medical writer, Medical Writing, EMA labelling Module 2.4 - Strong scientific accuracy and attention to detail - Understanding of Generic, Hybrid, and New drug applications - Proficiency in Clinical study design and protocol - Excellent communication skills and time management abilities - Specialization in Pharmacology is desired In this role, you will be a valuable asset in ensuring the accuracy and compliance of regulatory submissions while contributing to the successful development of medicines.,