Kyowa Kirin North America
Senior Director, GRA Development & Product Strategy Team Lead (Bone & Mineral)
Princeton, New Jersey · Director
Sponsorship not specified$265k-$285kDetected 44 days ago
ComplianceProduct StrategyProject ManagementBusiness DevelopmentRecruitingFDA RegulatoryLeadershipCommunicationCollaborationMicrosoft OfficeGxPRegulatory Affairs
About the role
- A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization.
- Working Conditions: Requires up to domestic and international travel.
- The anticipated salary for this position will be $265,000-$285,000.
Responsibilities
- Define and drive global regulatory strategies for all products within the assigned disease area, ensuring alignment with enterprise objectives and maximizing product value.
- Lead and develop a team of Global Regulatory Leads (GRLs), setting direction, building capabilities, and fostering a high-performance, accountable culture.
- Manage and coordinate regulatory activities, timelines, and deliverables across internal teams and external partners, ensuring alignment and on-time execution.
- Ensure compliance with global regulatory requirements, internal policies, and GxP standards, including support for inspections, audits, and governance processes.
- Drive operational excellence by leading process improvements, standardization efforts (e.g., SOPs/WIs), and adoption of best practices across Regulatory Affairs.
- Oversee external partnerships and due diligence activities, including vendor selection, alliance management, and regulatory support for business development transactions.
- Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet (CCDS) development and alignment with regional labeling requirements.
- Allocate and optimize regulatory resources across the portfolio, ensuring effective prioritization and support for key business objectives.
Requirements
- Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations
- Deep knowledge of global regulatory frameworks and guidelines, including major markets (e.g., FDA, EMA, ICH,PMDA) and their application to drug development and lifecycle management
- Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance
Nice to have
- Bachelor's degree in life sciences, pharmacy, or a related scientific discipline required.
- Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required
Skills
- Expertise in regulatory submissions and approvals, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval variations
- Strong understanding of global labeling requirements, including development and maintenance of Company Core Data Sheets (CCDS)
- Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness
- Strong proficiency MS Office Suite.
- Working Conditions:
- Requires up to domestic and international travel.
- 401K with company match
Compensation
- The anticipated salary for this position will be $265,000-$285,000.
Benefits
- Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution.
Company info
- In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Visa & Work Authorization
- ability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law
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