Requirements
- Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline
- 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.
Nice to Have
- Advanced degree (e.g., MS, PhD, PharmD, MBA)
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
Work Arrangement
Hybrid
Team
Structure: Oversee a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs.
Additional Information
- Requires up to domestic and international travel.
