Regulatory CMC Lead, Sterile Injectables & Generics

Breckenridge Pharmaceutical; Berkeley Heights (NJ); On-site; USD 145,000 - 165,000; Full time

Benefits offered by this job

Health benefits

Flexible work options

Bonus structure

Competitive compensation

Job summary

Breckenridge Pharmaceutical is seeking a Regulatory Affairs Manager to support regulatory CMC strategies and submissions for generic products, including complex sterile injectables and drug-device combinations. You will prepare, review, and submit filings throughout the product lifecycle while ensuring FDA compliance and eCTD standards.

Reporting to the Director of Regulatory Affairs, you will lead regulatory activities for assigned programs, collaborate with R&D, Analytical Development,

Qualifications

• 8+ years’ experience in regulatory affairs
• Must have a minimum of 5 years of regulatory experience with ANDA submissions for sterile injectable products
• Experience with inhalation or transdermal dosage forms is a plus
• Knowledge of combination product or Drug device regulations

Responsibilities

• Lead the preparation, review, and timely submission of high-quality CMC regulatory filings for sterile injectable products
• Develop and execute U.S. regulatory CMC strategies for complex generic products
• Serve as the Regulatory CMC lead for assigned development programs and support product development from early-stage through commercialization
• Provide regulatory guidance to cross-functional teams to ensure submissions are compliant with FDA regulations and QbD principles
• Mentor junior Regulatory Affairs staff and support senior management with risk evaluations

Skills

Regulatory affairs

ANDA submissions

Sterile injectables

Drug-device regulations

Attention to detail

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Advanced degree preferred

Job description

Breckenridge Pharmaceutical is seeking a Regulatory Affairs Manager to support regulatory CMC strategies and submissions for generic products, including complex sterile injectables and drug-device combinations. You will prepare, review, and submit filings throughout the product lifecycle while ensuring FDA compliance and eCTD standards.

Reporting to the Director of Regulatory Affairs, you will lead regulatory activities for assigned programs, collaborate with R&D, Analytical Development,