Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
Senior Regulatory Affairs Associate, Sun Pharmaceuticals Industries Inc., Princeton, NJ. Work closely with the Regulatory Affairs Director and CMC Associates to ensure the compliance and completion of assigned activities and provide regulatory strategic input and compliance with FDA regulations, guidance, and applicable industry guidelines to internal and external stakeholders, and ensure the implementation. Responsible for pre-approval submission activities and post-approval activities including submissions compilation and eSub. Utilize and apply pharmaceutical regulations when providing regulatory advice and guidance to company personnel. Advise team on availability of product specific bioequivalence requirements on FDA’s website for new projects in pipeline. Provide guidance related to dose proportionality and inactive ingredients quantities in proposed formulation. Prepare and submit controlled correspondences and meeting requests to the FDA. Prepare/Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Escalate the review findings to Director, Regulatory Affairs for timely resolution. Proactively assess all submissions for GAP analysis and create a summary report for anticipated deficiencies. Assist Director, Regulatory Affairs during interactions with FDA for status updates on submissions pending approval. Work cross-functionally with other Sun Pharma sites, project management, and R&D departments. Stay informed with current updates on FDA website, webinars, blogs, new draft/final guidance and federal register notices which impact regulatory activities and filings. Maintain regulatory databases by regularly updating information for completeness and ensuring correctness. Assist Director, Regulatory Affairs in planning deficiency response strategies’ and coordinate with all stakeholders in preparing for deficiency responses. Assist Director, Regulatory Affairs in deficiency response submissions. Review and assess the post approval changes under Director, Regulatory Affairs supervision. Coordinate documents for regulatory affairs, prepare and submit annual reports. 40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m.
Must have a Master’s degree in Regulatory Affairs or a related field, plus 2 years of related Pharmaceutical Industry work experience in Regulatory Affairs.
Must also possess the following:
12 months experience with ANDA submissions and regulatory documentation system
12 months experience with CMC
Please apply to: Human Resources, Sun Pharmaceutical Industries Inc., 270 Prospect Plains Road, Cranbury, NJ 08512. Please reference Job-ID: 789216.