Regulatory Strategist

Job Overview:

Works directly with GRA Leadership, GRA personnel, and client development teams to support the development and execution of regulatory strategies across all stages of product development. Candidate will collaborate with senior regulatory strategists and cross-functional subject matter experts to develop regulatory pathways, assess regulatory risks, and provide strategic recommendations to clients. Candidate will contribute regulatory expertise to business development initiatives, proposals, bid defenses, and client presentations. Additional responsibilities include supporting the development of regulatory thought leadership, maintaining awareness of evolving global regulatory requirements, and contributing to strategic initiatives within GRA. The Regulatory Strategy Associate providesregulatory support forthe development of clients’ products, including drugs, biologics, medical devices, diagnostics, and cell and gene therapy products.

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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