Sr. Associate Medical Writing RA

Role Overview: You will be responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. Your role will involve preparing complex CTD modules, conducting quality control of submissions, performing gap analysis, and providing support in responding to regulatory queries. Collaboration with cross-functional teams to support team development and process improvement will also be a part of your responsibilities. Key Responsibilities: - Author high-quality medical and regulatory documents following global guidelines, including Module 2 components like Quality Overall Summary, Nonclinical Overview, and Clinical Overview. - Ensure consistency, scientific accuracy, and regulatory compliance across all documents. - Perform Quality Control (QC) reviews of various documents such as SPC, PI, PIL, RMP, compiled modules for small molecules and biosimilars, SPL, BE templates, TIF, aggregate reports, and expert reports to ensure high quality and timely deliveries. - Conduct gap assessments for small molecules and biosimilar products, evaluate data to identify deficiencies affecting product submissions, and propose corrective actions through structured gap reports/sheets. - Assist in responding to regulatory queries by evaluating existing documents, conducting literature searches, and working with cross-functional teams to ensure customer satisfaction. - Provide mentorship, on-the-job training, and guidance to team members, and identify training needs for self and the team regularly. Qualification Required: - Bachelor's/Master's/PhD in Life Sciences, Pharmacy, Biotechnology, or related field. - Minimum 3-7 years of experience in regulatory/medical writing. - Strong understanding of CTD format and global regulatory guidelines like 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. Additional Company Details: DDReg Pharma Pvt Ltd offers you the opportunity to contribute to key regulatory submissions, exposure to global health authority expectations, a continuous learning environment for skill development, and a collaborative work culture.,