Senior Regulatory Affairs Specialist

3 days ago

North Plainfield, United States MedixTM Full time

We are looking for an experienced RA professional to join a large and growing pharmaceutical company. Interested candidates MUST HAVE the following experience (candidates without will not be considered):Recent experience authoring original ANDA submissions (including relevant eCTD sections) for complex generics and/or combination products.Must have submission experience with products with a Bio study component.Must be open to working on site at least 2 days a week.Responsibilities:Compile and submit ANDAs, supplements (CBE/PAS), annual reports, and labeling supplements in compliance with FDA requirements.Author relevant eCTD sections using company templates and ensure files are properly formatted with bookmarks, hyperlinks, and metadata.Evaluate proposed product and process changes against current FDA guidance and industry standards. Recommend appropriate filing strategies, timelines, and risk-based approaches for submission planning and execution.Support regulatory strategy and submissions for complex generics and combination products (e.g., transdermal systems, injectables, drug-device combinations).Create and maintain internal templates, trackers, and tools to manage regulatory planning and combination product submissions.Provide regulatory support for Design History Files (DHFs), ensuring consistency and alignment with FDA expectations for device related documentation.Prepare formal meeting packages and briefing documents under GDUFA III, including pre-submission and mid-cycle meetings.Coordinate with internal departments and external partners for documentation collection, timeline management, and regulatory compliance.Lead regulatory activities for post-approval changes including site transfers, analytical method updates, container/closure system changes, and alternative sourcing of materials.Participate in product development from early-stage formulation to final submission, incorporating FDA feedback and seeking regulatory guidance when appropriate.Draft, review, and maintain product labeling and promotional labeling, ensuring alignment with current regulations and internal policies.Review technical documentation and provide regulatory guidance to internal and external stakeholders. Ensure all submissions meet FDA standards, cGMP requirements, and Quality-by-Design (QbD) principles.Ensure submission documentation is accurate, complete, and in compliance with applicable FDA regulations and company quality standards.Requirements: 5+ years' experience in pharmaceutical regulatory affairs.Experience with complex and combination products and knowledge of FDA expectations.Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software.Independently compiled and filed ANDAs

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