CMC Regulatory Manager – Generics & Sterile Injectables

Breckenridge Pharmaceutical Inc; Berkeley Heights (NJ); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Health benefits

Bonus program

Flexible work options

Job summary

Breckenridge Pharmaceutical Inc. in Berkeley Heights, NJ is seeking a Manager Regulatory Affairs to lead regulatory CMC strategies for generic drugs, including sterile injectables and drug-device combinations.

The role partners with the Director of Regulatory Affairs to prepare high-quality filings and ensure FDA compliance. You will coordinate submissions, support due diligence for business development, guide cross-functional teams, and mentor junior staff while navigating 21 CFR rules, eCTD

Qualifications

• 8+ years of experience in regulatory affairs.
• Minimum 5 years of regulatory experience with ANDA submissions for sterile injectables.
• Experience with inhalation or transdermal dosage forms is a plus.
• Knowledge of Drug-device regulations.

Responsibilities

• Lead preparation and submission of CMC regulatory filings for sterile injectables.
• Develop and implement US regulatory CMC strategies.
• Assist in regulatory due diligence for business development.
• Provide regulatory guidance to cross-functional teams.
• Support labeling and promotional labeling review with Compliance.

Skills

Regulatory affairs

ANDA submissions

Sterile injectables

FDA regulations

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in Pharmacy or related field

Advanced degree preferred

Job description

Breckenridge Pharmaceutical Inc. in Berkeley Heights, NJ is seeking a Manager Regulatory Affairs to lead regulatory CMC strategies for generic drugs, including sterile injectables and drug-device combinations.

The role partners with the Director of Regulatory Affairs to prepare high-quality filings and ensure FDA compliance. You will coordinate submissions, support due diligence for business development, guide cross-functional teams, and mentor junior staff while navigating 21 CFR rules, eCTD