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

About the role

A Senior Director, GRA Development & Product Strategy Team Lead is responsible for developing and implementing regulatory strategies, leading a team of Global Regulatory Leads (GRLs), and overseeing global projects. This role may serve as a Regional Regulatory Lead (RRL) based on business needs.

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.

Requirements

• 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; relevant industry experience may be considered in lieu of advanced education.
• 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.

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

Pay

$265,000 - $285,000

Schedule

Hybrid