This is an immediate opening (for temporary position, possible extension) at Sun Pharma, Princeton, NJ location as a Regulatory Affairs Associate. Work closely with Regulatory Affairs Manager and Regulatory Affairs 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.
• Prepare the submissions (ANDAs, amendments, supplements, annual reports) to support commercial business and to be-in compliance to FDA regulations.
• Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Escalate the review findings to Manager, RA for a timely resolution.
• Review and implement RLD Labeling updates, prepare labeling submissions, and review promotional materials and submit to the FDA for review, as necessary.
• Initiate change control process and coordinate with other departments to ensure timely implementation of revised labeling.
• Prepare, review and submit eCTD submissions and SPLs.
• Proactively assess all submissions for GAP analysis and summarize a report for anticipated deficiencies prior to submission to the FDA.
• Work cross-functionally with other sites/CMOs, project management and R&D departments.
• Maintain regulatory databases by regularly updating information for completeness and ensuring correctness.
• Assist Manager, RA in planning deficiency response strategies’ and coordinate with all stake holders in preparing for deficiency responses.
• Review and prepare RA assessments of change control for completeness and accuracy under RA Manager’s supervision
• Perform other duties as assigned.
BS in Science or related degree
1-2 years of experience in Pharmaceutical Industry preferably in Regulatory Affairs.
• Must be highly organized and have the ability to meet critical timelines
• Able to work as part of a team and achieve assigned timelines
• Very strong organizational skills that is necessary to manage and multi-task various activities.
• Detail oriented with strong communication and organizational skills
• Excellent regulatory, technical, and problems solving skills
• Experience and knowledge in the preparation of major regulatory submissions and supportive documents.
• Excellent knowledge of electronic submission guidance documents and regulations
• Working knowledge of ANDA, and post-approval submission requirements and guidelines.
• Demonstrate the ability to provide regulatory assessments to other departments with little or no supervision.
• Demonstrate the ability to coordinate submissions independently in a time intensive situation
• Good computer skills. Eg. Microsoft office, adobe professional, etc.
• Knowledge of technical documents such as Specifications, Methods and Validations
• eCTD submissions and SPLs using software.