Senior Regulatory Affairs Associate
$88k/y-$125k/y
4 days ago
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OnsiteFull-timeSenior
Summary
Breckenridge Pharmaceutical is seeking a Senior Regulatory Affairs Associate to join their team in Berkeley Heights, NJ. The role involves managing key regulatory submission activities and supporting product lifecycle management for complex generics and combination products.
About the Role
As a Senior Regulatory Affairs Associate, you will be responsible for compiling and submitting ANDAs, supplements, and annual reports in compliance with FDA requirements. You will evaluate product changes, support regulatory strategy for complex products, and prepare meeting packages under GDUFA III. Additionally, you will coordinate with internal and external partners, lead regulatory activities for post-approval changes, and ensure all submissions meet FDA standards.
About You
Required:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
- 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.
- Familiar with cGMP requirements.
Preferred:
- Advanced degree.
- Sterile products experience.
Benefits
- Flexible approach to how we work.
- Health benefits and time-off programs.
- Competitive compensation packages.
- The anticipated annual salary for this role is $88k–$125k.
Breckenridge Pharmaceutical
Breckenridge Pharmaceutical, the American affiliate of Towa International (Barcelona, Spain), develops and markets high-quality and cost-effective generic drugs in the United States. Our products are developed organically and through strategic partnerships with manufacturers from around the world. At Breckenridge, we are committed to ensuring a stable supply and the highest quality standards enabling our customers to collaboratively contribute to our company’s goal of improving people’s health. With our work, we aim to strengthen the resilience of healthcare, improve equitable access to medical services for all, and create a healthy environment for future generations.
Berkeley Heights, NJ