Manager, Commercial Regulatory Affairs
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma America, Inc. (MTPA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation, is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.
With the recent FDA approval and availability in the U.S. of RADICAVA® (edaravone) MTPA is rapidly expanding our operation across all functional areas to launch this new product in the U.S. market. Concurrently, the company is expanding its research efforts and exploring collaborations with partners to discover and bring treatments to market for unmet medical needs including orphan diseases. We currently seek motivated professionals who share our vision of scientific excellence, innovation, and unwavering dedication to improving the lives of patients.
The Manager, Commercial Regulatory Affairs is responsible for the coordination and tracking of regulatory activities and submissions associated with the company’s post-marketing regulatory activities. Regulatory activities pertain primarily to marketed products in US and Canada, and post-marketing development and maintenance.
- Supports supervisor/regulatory reviewer of the Promotional Materials Review Committee (PMRC), a cross-functional team of representatives from various business areas (Marketing, Market Access, Sales Training, Communications/Public Relations, Legal, Medical Affairs, and Regulatory Affairs).
- Collaborates closely with the PMRC Manager and other members to quickly resolve issues that arise (escalating to higher levels if needed) in order to efficiently move documents towards final regulatory submission.
- Supports supervisor/regulatory reviewer of the Non-Promotional Review Committee (NPRC).
- Provides overall management, quality control (QC) and tracking for submission processes:
- Ensures timely QC check of all promotional materials in electronic format (e.g., advertisements, promotions, press materials, etc.) to be submitted to FDA’s Office of Prescription Drug Promotion (OPDP) and Canada’s Pharmaceutical Advertising Advisory Board (PAAB)
- Resolves issues that arise during the QC check of promotional materials
- Prepares timely, high quality and error-free submissions to OPDP and PAAB
- Coordinates e-submission with submission agency and/or internal submission team
- Maintains submission logs for OPDP and PAAB
- Disseminates/coordinates approval notifications with teams
- Supports labeling control:
- Coordinates version control of package inserts
- Serves on QC check of package inserts and packaging labels
- Serves as secretary of the Labeling Committee
- Documents/tracks changes as required, utilizing designated spreadsheets/logs for label version control, other document control, and always maintaining accurate, auditable databases and files
- Assists various post-marketing development projects as assigned.
- Assists preparation of NDA Annual Reports, safety updates, and Phase 4 FDA commitments.
- Works closely with Mitsubishi Tanabe Pharma Development America (MTDA) for publishing and submissions.
- Stays abreast of new regulatory guidance that might relate to Advertising & Promotions, particularly any new regulations and guidance coming from OPDP and PAAB. Advises and updates supervisor and related teams, as appropriate, to ameliorate potential negative business impacts.
- Works with an eye towards continuous process improvement, bringing recommendations to supervisor and then implementing approved ideas as directed.
- Performs other duties as required.
- Bachelor’s degree, preferably in a science field (e.g., Pharmacy, Chemistry, Molecular Biology, etc).
- Minimum 3 years of experience in Regulatory Affairs which included specific experience with Regulatory Affairs Advertising & Promotions
- Knowledge of FDA regulatory framework, particularly OPDP regulations and guidance
- Strong organizational/project management strengths with proven ability to multitask while consistently meeting deadlines
- Outstanding detail orientation coupled with strong quality control and proofreading skills
- Demonstrated ability to contribute successfully in a multi-disciplinary team environment / matrix organization
- Strong software skills:
- proven competency in MS Office including Excel
- competency with Adobe products is a pluss
- previous experience using Veeva Vault PromoMats is a plus
Job posted: 2020-06-05