Sr Associate Regulatory Affairs

Job Description

Job Description

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

About the Role

The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-approval changes), supporting commercial product lifecycle management, and providing backup to the Director of Regulatory Affairs. The role plays an essential part in ensuring timely, compliant regulatory filings and strategic input for product development, with particular focus on complex generics and combination products. This role also includes supporting GDUFA III-related meeting package preparation.

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.
• Represent Regulatory Affairs in internal cross-functional meetings and external partner calls, as needed.
• 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.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field required.
• Advanced degree preferred.

Required Skills

• 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.