Manager, Drug Regulatory Affairs
The Manager Drug Regulatory Affairs is responsible for planning, managing and tracking regulatory documentation, and successful preparation and filing of submissions (DMF, ANDA, NDA) in the required electronic format. This role serves as the system owner for regulatory information tools and technologies, and develops processes to ensure submission are complete and comply with applicable regulatory requirements, in a fast-paced environment. This individual collaborates with cross-functional teams (RA, QA, IT, etc.) to bring excellence in regulatory planning and operational execution for development programs and post-approval management.
Spend your days:
- Working closely and partner with the Quality, Manufacturing and Development teams to track deliverables for preparation of regulatory submissions and other correspondence with FDA. Update management regarding status of deliverables and identify critical activities/risks for timeline.
- Contributing to the creation and implementation of development and post-approval regulatory strategies for assigned projects and programs.
- Contributing to the planning, preparation and review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.
- Managing vendors in support of electronic publishing and other aspects of regulatory operations
- Managing establishment registrations and drug listing requirements in compliance with FDA requirements, manage payment of establishment registration fees, and other fees (e.g.,GDUFA) associated with regulatory filings
- Providing operational support as required for internal audits, FDA audits and FDA CGMP/GLP inspections
- Assisting with imports, ensuring necessary documentation is provided for FDA clearance at Port of Entry
- Assisting in tracking regulatory commitments and change control activities to ensure manufacturing changes are reported to authorities in accordance with regulatory requirements
- Managing preparation of Annual Reports to FDA in compliance with obligations of the application holder
- Providing leadership in regulatory information management, and as system owner for Phlow’s EDMS
- Maintaining up-to-date knowledge of global standards and procedures for regulatory submissions, including FDA ESG, eCTD, IDMP, and ensure Phlow’s standards and procedures are compliant with these requirements.
Bring with you:
- An understanding of Regulatory submission processes from document authoring and management, submission publishing, to regulatory information management and archive
- Experience with Drug Master File (DMF) and ANDA submissions
- Experience in implementing EDMS applications
- Experience wtih eCTD submission requirements and ESG
- Must be proficient in MS Sharepoint, MS Office 360 (MS Word, MS Excel, MS Powerpoint), Adobe Acrobat Pro.
- Demonstrated organizational skills, strong verbal and written communication skills, attention to detail
- Experience developing business processes, Standard Operating Procedures, and Work Instructions preferred
- Ability to work in a cross-functional team environment with changing timelines and priorities required.
Bachelor’s degree in relevant discipline, with scientific discipline preferred.
5 or more years of pharmaceutical industry experience with at least 3 years regulatory submissions experience. Work experience must include U.S. submissions to FDA of chemistry, manufacturing and controls (CMC) information.
About Phlow: Phlow Corporation (“Phlow”) is a public benefit pharmaceutical manufacturing company dedicated to reliably supplying affordable, high-quality, essential medicines through U.S. based advanced manufacturing processes. The company manufactures precursor chemical ingredients, active pharmaceutical ingredients (API), and finished pharmaceutical products, domestically for essential medicines critical to the Nation’s healthcare. To help ensure the quality, safety, and affordability of pharmaceutical products of strategic importance to the United States, Phlow utilizes advanced manufacturing platforms, including continuous manufacturing, to provide essential medicines to its customers, health systems, and government partners.
Phlow’s commitment to diversity includes recognition that our mission is best advanced by the leadership and contributions of colleagues of diverse backgrounds, beliefs, and culture. Recruiting and mentoring staff to create an inclusive organization that reflects our shared values is a priority.
EEO Statement: Phlow provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability or genetics. In addition to federal law requirements Phlow complies with applicable state and local laws governing nondiscrimination in employment in every location in which the organization has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Learn more here
Job posted: 2020-08-31