About the Company
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 Manager is responsible for supporting the development and execution of regulatory CMC strategies and submissions for generic drug products, including complex sterile injectables and drug-device combination products. The role is accountable for preparing, reviewing, and submitting high-quality regulatory filings throughout the product lifecycle while ensuring compliance with U.S. FDA regulations and current guidance documents.
Working in close collaboration with the Director of Regulatory Affairs, the Regulatory Affairs Manager serves as the Regulatory CMC lead for assigned development programs and assists in developing and implementing regulatory strategies from early product evaluation through commercialization. Other responsibilities include supporting due diligence activities for Business Development opportunities, evaluating regulatory risks, and representing Regulatory Affairs on cross-functional project teams.
This position requires extensive hands-on CMC experience with ANDA compilation, lifecycle management, FDA deficiency responses, regulatory meeting preparation for sterile injectable and/or complex generic products. The Manager partners closely with Research & Development, Analytical Development, Manufacturing, Quality, Clinical/Bioequivalence, Supply Chain, Project Management, and external development and manufacturing partners to facilitate timely regulatory submissions and approvals.
Responsibilities
- Lead the preparation, review, and timely submission of high-quality CMC regulatory filings, including ANDAs, amendments, annual reports, controlled correspondence, FDA meeting packages, and post-approval supplements for sterile injectable products ensuring compliance with FDA regulations and eCTD requirements.
- Assist in developing and executing U.S. regulatory CMC strategies for complex generic products, including sterile injectables and drug-device combination products.
- Serve as the Regulatory CMC lead for assigned development programs, working closely with the Director of Regulatory Affairs to provide regulatory support to product development from early-stage formulation through FDA approval and commercialization.
- Support regulatory activities for complex generic and combination products, including drug-device systems, ensuring compliance with applicable FDA regulations, including 21 CFR Part 4, FDA guidance on Threshold Analyses, Design and Development files, design controls, and device constituent documentation.
- Provide technical regulatory guidance to cross-functional teams, including Research & Development, Analytical Development, Manufacturing, Quality, Clinical/Bioequivalence, Project Management, Supply Chain, Commercial, and external partners to support product development and lifecycle management.
- Evaluate manufacturing, formulation, analytical method, container closure, site transfer, supplier, and process changes and provide recommendations regarding appropriate regulatory pathways, submission strategies, timelines, and regulatory risks.
- Prepare and coordinate responses to FDA Information Requests, Information Requests (IRs), Deficiency Letters, Complete Response Letters (CRLs), and other correspondences.
- Provide regulatory due diligence support for Business Development activities.
- Review technical development documentation and provide regulatory guidance to internal teams and external partners to ensure submissions are scientifically sound and compliant with FDA regulations, cGMP requirements, and Quality-by-Design (QbD) principles.
- Collaborate with internal departments and external partners to ensure regulatory deliverables support project timelines, critical path activities, and successful product launches.
- Support the preparation, review, and maintenance of product labeling and promotional labeling in collaboration with the Labeling group, ensuring compliance with FDA regulations and company procedures.
- Develop and maintain regulatory templates, trackers, work instructions, and best practices to improve submission quality, operational efficiency and regulatory compliance.
- Mentor and provide technical guidance to junior Regulatory Affairs staff, supporting professional development and fostering regulatory excellence within the department.
- Assist in preparing executive summaries, technical assessments, regulatory recommendations, and risk evaluations for senior management to support informed business decisions.
- Perform other duties and special projects as assigned.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field required.
- Advanced degree preferred.
- Desired: MBA or similar graduate degree preferred.
Required Skills
- 8 + years’ experience in regulatory affairs required.
- 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.
- Excellent attention to detail and organizational skills.
- Strong analytical and problem-solving abilities.
- Effective communication and interpersonal skills.
- Ability to work both independently and collaboratively in a team environment.
Pay range and compensation package
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:
- Flexible approach to how we work
- Health benefits and time-off programs
- Competitive compensation packages with bonus structure
- The anticipated annual salary for this role is $145,000 – 165,000.
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.