Senior Regulatory Affairs Specialist – Complex Generics

Breckenridge Pharmaceutical, Inc.; Berkeley Heights (NJ); Vor Ort; USD 90.000 - 125.000; Vollzeit

Benefits dieser Stelle

Flexible approach to how we work

Health benefits and time-off programs

Competitive compensation packages

Zusammenfassung

Breckenridge Pharmaceutical, Inc. in Berkeley Heights, NJ, is seeking a Regulatory Affairs Senior Associate to manage regulatory submissions (ANDAs and post-approval changes) and lifecycle support for complex generics and drug-device combinations.

You will author eCTD sections, advise on filing strategies, prepare GDUFA III meeting packages, and collaborate with cross-functional teams to ensure FDA compliance and timely filings.

Qualifikationen

• 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

Aufgaben

• 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.
• Support regulatory strategy and submissions for complex generics and combination products.
• 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 with FDA expectations.
• Prepare formal meeting packages and briefing documents under GDUFA III.
• Coordinate with internal departments and external partners for documentation collection and regulatory compliance.

Kenntnisse

Regulatory affairs experience

eCTD software

FDA compliance

Documentation skills

Ausbildung

Bachelor's degree in Pharmacy/Chemistry/Biology

Advanced degree preferred

Tools

MS Word

Excel

Adobe Acrobat

eCTD software

Jobbeschreibung

Breckenridge Pharmaceutical, Inc. in Berkeley Heights, NJ, is seeking a Regulatory Affairs Senior Associate to manage regulatory submissions (ANDAs and post-approval changes) and lifecycle support for complex generics and drug-device combinations.

You will author eCTD sections, advise on filing strategies, prepare GDUFA III meeting packages, and collaborate with cross-functional teams to ensure FDA compliance and timely filings.