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
Qualifications
Required Skills
Compensation & Benefits
At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:
Equal Opportunity Statement
Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
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