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Manager, Regulatory Affairs Su...
The Manager, Regulatory Affairs-Submissions is responsible for the coordination of regulatory efforts relating to the compilation, review and submission of ANDAs, amendments, and post approval submissions to support the company’s internal and external R&D pipeline and commercial products.
Essential Duties and Responsibilities:
· Reviews technical documents in detail to ensure clarity of data presentation, accuracy of data interpretation, logic, consistency and compliance with Regulatory requirements. Ensures that regulatory quality is incorporated at each step of the document development e.g. troubleshoots data and resolves problems with technical issues such as test methods and instrumentation.
· Reviews change control in order to assign appropriate regulatory determination and ensure proper supporting documentation is available to accurately define change.
· Manage the compilation, review and submission process for ANDA’s, subsequent amendments, including SPL/PLR (labeling), all interactions and communications with the FDA from product inception to approval, including regulatory support during Pre-Approval Inspections for assigned projects.
· Manage the compilation, review and submission process for Post Approval submissions, including SPL/PLR (labeling), including all interactions and communications with the FDA.
· Communicate with R&D Formulations, Technical Operations, Analytical R&D, Manufacturing, Quality Control, Quality Assurance and Par’s internal audit group throughout the development and submission process to ensure all submission related documents (batch manufacturing and control records, packaging records and analytical reports) are assembled and reviewed on an ongoing basis, with problems identified and addressed concurrently.
· Communicate and effectively follow-up with the FDA on various regulatory issues.
· Interact and communicate with Project Management on submission and project time lines.
· Utilize and remain current with internal/external electronic submission initiatives.
· Prioritize work flow to maximize efficiency.
· Interface with internal/external legal counsel and Business Development on patent infringement issues, paragraph IV certifications and notices to patent holders.
· Insure that the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and USPTO databases are monitored on a regular basis for updated patent and exclusivity information that may affect potential or pending ANDA products.
· Monitor FDA CDERNEWS and applicable web sites for new Orange Book listings, competitor Paragraph IV Certifications/Approvals and New Guidances, labeling updates that may impact pending/future ANDAs and provide impact on project/company.
· Conduct regulatory review of innovator products, associated patent and exclusivity status, including pediatric extensions for new product submissions.
· Conduct regulatory due diligence for internal and/or external R&D projects.
· Participate and represent department at project meetings.
· Represent the company through involvement in professional associations and attendance at various seminars and workshops.
Education and or Experience:
· Bachelor’s degree in a scientific or other related discipline or an equivalent overall level of knowledge based upon previous work experience.
· 5 – 8 years experience in regulatory affairs.
· Knowledge of government regulations, policies and procedures and current Good Manufacturing Practices.
Par Pharmaceutical offers a comprehensive benefit package, including medical, dental, vision, life and disability and 401(k).