Sr. Associate_ Medical Writing_ RA

As an experienced Regulatory Affairs Medical Writer at DDReg Pharma Pvt Ltd, your role will involve drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. You will be responsible for preparing complex CTD modules, performing quality control of submissions, conducting gap analysis, and supporting in responding to regulatory queries. Collaboration with cross-functional teams to support team development and process improvement will be a key aspect of your responsibilities. Key Responsibilities: - Author high-quality medical and regulatory documents following global guidelines. - Prepare complex regulatory documents including Module 2 components and regulatory strategy reports. - Ensure consistency, scientific accuracy, and regulatory compliance across all documents. - Perform quality control reviews of simple and complex documents such as SPC, PI, RMP, and compiled modules for small molecules and biosimilars. - Conduct gap assessment for small molecules and biosimilar products and draft structured gap reports/sheets with proposed corrective actions. - Support regulatory query responses, conduct literature searches, and collaborate with cross-functional teams to ensure customer satisfaction. - Provide mentoring, training, and guidance to team members, resolving technical/medical doubts and identifying training needs. Qualifications Required: - Bachelors/Masters/PhD in Life Sciences, Pharmacy, Biotechnology, or a related field. - 3-7 years of experience in regulatory/medical writing. - Strong understanding of CTD format and global regulatory guidelines such as ICH, FDA, EMA, CDSCO. - Hands-on experience in Module 2 documents, data analysis for gap assessment, and QC of regulatory deliverables. - Excellent written communication, analytical skills, and attention to detail. - Proficiency in MS Office and documentation systems. Join DDReg Pharma Pvt Ltd for the opportunity to contribute to key regulatory submissions, gain exposure to global health authority expectations, develop your skills in a continuous learning environment, and be part of a collaborative work culture.,