Senior Director, GRA Development & Product Strategy Team Lead (Bone & Mineral)

Kyowa Kirin North America•Princeton, NJ

9d•$265,000 - $285,000•Hybrid

About The Position

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. 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. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Director, GRA Development & Product Strategy Team Lead is responsible for the developing and implementing regulatory strategies, while leading people amd managing global projects. This role oversees a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs.

Requirements

Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline required.
Minimum 12+ years extensive regulatory affairs experience within the pharmaceutical, biotechnology, or related industry, including global development and lifecycle management, with a focus on bone and mineral disease areas.
Proven leadership experience, including managing and developing high-performing regulatory teams and/or leading through other leaders (e.g., GRLs)
Demonstrated success in developing and executing global regulatory strategies across multiple regions and product stages (development through post-approval)
Significant experience interacting with health authorities, including leading regulatory agency meetings and negotiations
Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations
Experience supporting business development activities, including regulatory due diligence for in-licensing, out-licensing, or partnerships
Strong collaboration across cross-functional teams including regulatory affairs, government affairs, clinical, legal, and R&D.
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
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)
Advanced regulatory strategy development and risk management skills, with the ability to anticipate challenges and drive solutions
Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness
Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance
Strong organizational and project management skills with the ability to manage multiple initiatives simultaneously.
Exceptional communication and influencing skills, with the ability to clearly articulate complex regulatory strategies, risks, and requirements to diverse audiences, including health authorities, senior leadership, and cross-functional teams, to drive alignment and informed decision-making.
Strong proficiency MS Office Suite.
Requires up to domestic and international travel.

Nice To Haves

Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required; relevant industry experience may be considered in lieu of advanced education.

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.
Shape and integrate regulatory strategy into global product development and lifecycle plans in close partnership with cross-functional stakeholders.
Oversee and ensure execution of regulatory strategies, including global submissions, approvals, and post-approval activities across assigned products and projects.
Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution.
Guide and approve global regulatory submission plans, including marketing applications, labeling (e.g., CCDS), and key lifecycle deliverables.
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.
Assess and communicate regulatory risks, emerging trends, and competitive intelligence, escalating issues and recommending mitigation strategies as appropriate.
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.
Contribute to organizational leadership, including participation in RA Functional Teams (RAFTs), budget oversight, and fostering collaboration across Regulatory Affairs and the broader organization.
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.
Recruit and build organizational capability by leading talent acquisition, succession planning, and ongoing training initiatives within the regulatory function.
Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles, and the Global Regulatory Affairs Vision.

Benefits

401K with company match
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well-Being and Work/Life Programs
Life & Disability Insurance
Concierge Services
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards