Senior Regulatory Affairs Specialist

Job Overview/Objectives

This individual will establish regulatory affairs business processes to ensure compliance with all relevant governmental regulatory authorities, with a near term emphasis on US FDA and Japanese regulatory authorities. The categories of supported products include IV solutions and other drug products regulated under CFR 210 and 211, biological products, APIs, combination products and medical devices. The position will interact with internal program/product managers, external contract research and contract manufacturing organizations (CDMO/CMO) which are developing our research pipeline products.

The position is responsible for setting strategy, coordinating and compliance of submissions to governmental regulatory agencies relevant for OPF-A’s product portfolio (e.g. NDA, ANDA, 510K, BLA, supplemental submissions, submissions required to maintain post‑market compliance, etc.).

• Establish RA submission strategy for new products
• Prepare and maintain both NDA and ANDA submissions
• Serve as the primary communication contact with US FDA (CDER, CDRH, CBER, etc.)
• Prepare and maintain 510K and combination product submissions/licenses
• Draft labeling for U.S. Prescription Drugs
• Translate and review package inserts and interview forms in English
• Keep up to date on changes to the regulatory environment in relevant markets and communicate business impacting developments to impacted departments

• Coordinate with OPF-Japan and OPF-America, or including Otsuka global entities to ensure RA business requirements are compliantly met
• Establish and maintain organization structure to address variable workload (contractor, part‑time and FTE as required for changing business conditions)
• Provide cost estimates for regulatory requirements (submissions, maintenance fees, licenses, etc.)
• Help prepare and maintain OPFA’s RA budget

• Demonstrates emotional intelligence with the ability to engage effectively with senior leaders and decision‑makers while maintaining alignment with organizational objectives and quality standards.
• Proven ability to build consensus among multiple stakeholders and drive alignment within established project timelines
• Excellent written and verbal communication skills in English
• Skilled in facilitating productive meetings both virtually (e.g., via MS Teams) and in person, ensuring efficiency and actionable outcomes.
• Startup‑minded and adaptable, with a strong hands‑on, roll‑up‑your‑sleeves mindset
• High level of integrity, discretion, and professionalism
• Strong problem‑solving, analytical, and interpersonal skills
• Resilient and persistent, demonstrating grit and perseverance in overcoming challenges

• Undergraduate degree in a relevant scientific field, advanced degree(s) preferred
• Minimum 5 years of experience with US FDA, experience with other regulatory agencies desirable
• Legally authorized to work in the United States

• Must be willing and able to travel locally and internationally
• Flexibility to attend meetings with Japan HQ when needed due to time zone differences
• Hybrid work style required: in‑office three days per week, with additional on‑site presence as needed based on business requirements
• Must be able to occasionally lift and carry items weighing up to 20 pounds

• Must be willing and able to travel locally and internationally
• Flexibility to attend meetings with Japan HQ when needed due to time zone differences
• Hybrid work style required: in‑office three days per week, with additional on‑site presence as needed based on business requirements
• Must be able to occasionally lift and carry items weighing up to 20 pounds