Regulatory Affairs Manager - Operations
Dayton, OH 43232
Manager Regulatory Affairs Operations – Pharmaceutical Company
Reports to: Senior Director Regulator
The position will serve to lead the Regulatory Operations Group in managing regulatory submission activities of R&D and lifecycle submissions to US FDA. This includes, but is not limited to the electronic build of submission, formatting, and publishing of pre-approval (R&D) and post-approval (lifecycle) submissions, such as original applications, amendments and deficiency responses, annual reports, supplements, supplement deficiency responses, REMS and Pharmacovigilance submission, and general correspondence for all regulatory submissions. Ensures compliance with policies, procedures, and applicable regulations. Extremely proficient with a Regulatory Information Management System (RIMS) software. Works closely with Senior Management on all issues surrounding submissions in order to obtain approvals for products. The candidate will be required to provide oversight for regulatory submission support to applicable stakeholders. Ensures all submission timelines are met in order to support the business, and ensure quality, accuracy and submission readiness. Responsible for managing and providing support to associates within the group.
- Responsible for managing the compilation, formatting and accuracy of the technical elements of electronic submissions in eCTD format utilizing the RIMS, as well as managing the publishing in accordance with applicable regulatory standards and guidances.
- Provides oversight and support to the business by interfacing with cross-functional departments to obtain required information and ensure submission compliance per regulatory procedures and Agency requirements. Performs thorough review of submissions to ensure quality and compliance to current eCTD requirements and standards. Works closely cross-functionally to ensure Master/Meta data associated with documents is current and compliant.
- Evaluates performance, provides coaching, and ensures direct reports are developing appropriate skills to meet the needs of the business. Ensures compliance with regulatory submissions made to the FDA and that internal policies and procedures, 21 CFR, FDA guidances, and other customer requirements are met.
- Stays current with emerging regulatory guidances, and industry expectations and standards necessary for all regulatory submissions as appropriate through training, seminars and investigating new technologies, and brings this information back to the relevant groups to effect change. Provides education and training on regulatory operation strategies and compliance issues to other functions. Identifies, develops, and implements new process improvements in order to ensure regulatory best practices and compliance to the constantly changing FDA requirements. Subject matter expert in the RIMS.
- Minimum of a bachelor’s degree required (Science related field)
- Experience Required:
- Previous management experience in a Pharmaceutical company
- Pharmaceutical experience minimum of 5 years of regulatory/ operations/ eCTD submission/ or related field
Additional Core Competencies:
- Comprehensive understanding and working knowledge of regulatory submission (eCTD) requirements for pre-approval and/or post-approval submissions for the US Market.
- Expert understanding of submission regulations and requirements for US market through working knowledge, FDA Guidance Documents and MAPPs, ICH Guidelines, Code of Federal Regulations as they pertain to pharmaceutical drug products.
- Consistently demonstrates the ability to ensure high quality submissions to US FDA.