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 in a science field (e.g., Pharmacy, Chemistry, Molecular Biology, etc.), with minimum 3 years of experience in Regulatory Affairs including specific experience with Regulatory Affairs Advertising & Promotions and post-marketing regulatory activities – OR - 7 years of experience in Regulatory Affairs including specific experience with Regulatory Affairs Advertising & Promotions and post-marketing regulatory activities
Minimum 3 years of experience in Regulatory Affairs including specific experience with Regulatory Affairs Advertising & Promotions and post-marketing regulatory activities
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
Internal Number: 2020-1456
About Mitsubishi Tanabe Pharma
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 (MTPC), 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.