Job Description

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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