Regulatory strategist

Summary of Responsibilities:

• Support the development and implementation of global and regional regulatory strategies for assigned client programs. Participate in cross-functional initiatives.
• Provide strategic regulatory input for proposals, bid defenses, and business development opportunities.
• Participate as the regulatory strategy representative within multidisciplinary product development teams and provide regulatory guidance to support development objectives.
• Support development of regulatory strategy training materials, regulatory intelligence communications, and client-facing scientific content.
• Identify, promote, and implement regulatory strategy best practices and innovative approaches to support successful product development.
• Support the preparation, planning and execution of interactions with Japanese health authorities, including PMDA and MHLW, as applicable.
• Contribute to regulatory risk assessments, gap analyses, and the development of mitigation plans for client programs.
• Collaborate with internal Fortrea subject matter experts to develop integrated regulatory and development strategies.
• Support the preparation of briefing packages, regulatory consultation materials, meeting requests, and responses to health authority inquiries.
• Maintain current knowledge of global and Japanese regulatory requirements, guidance, health authority expectations, and emerging trends, and communicate relevant developments to internal teams and clients.

Qualifications (Minimum Required):

• Bachelor’s or Master’s Degree in Life Sciences, Pharmaceutical Sciences, Medicine, or a related discipline.
• Knowledge of drug development and regulatory requirements in Japan is required; knowledge of regulatory requirements in other major regions is preferred.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Native-level Japanese language skills and business-level English proficiency required.

Experience (Minimum Required):

• Minimum of 5 years’ experience in Regulatory Affairs or Drug Development within the pharmaceutical, biotechnology, or CRO industry.
• Experience contributing to regulatory strategies and regulatory submissions in Japan is required; experience in additional major markets, such as the US or EU, is preferred.
• Working knowledge of CMC regulatory requirements and experience incorporating CMC considerations into regulatory strategies are preferred.
• Experience supporting or participating in health authority interactions and regulatory consultation activities required; experience leading such activities is preferred.
• Demonstrated ability to evaluate regulatory risks and develop or contribute to strategic recommendations for product development programs.

Physical Demands/Work Environment:

• Office environment.
• Some flexibility in scheduling may be required.
• Travel Requirement:
• Global travel may be required for approximately 5% of working time,including occasional overnight travel.
• Travel is primarily to the United States.

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