XE
Xcel EnergyRegulatory Policy Specialist
Regulatory Policy Specialist developing regulatory case filings and strategies at Xcel Energy. Collaborating with senior management to ensure compliance and effective communication with stakeholders.
About the role
- Create high-quality global regulatory strategies and manage Health Authority interactions to achieve development and business objectives
- Identify and communicate potential regulatory opportunities and risks, and develop mitigation strategies
- Utilize regional expertise to define and execute global regulatory strategies and engage with Health Authorities
- Offer strategic regulatory input on key development, labeling, and promotional documents
- Oversee submission planning, guide contributing authors, and critically review submission documentation
- Lead interactions with regulatory and development management and external consultants for strategic input
- Provide strategic regulatory and development input into Business Development & Licensing due diligence evaluations
- Maintain compliance with global regulatory requirements and internal policies, and coordinate regulatory compliance activities
- Lead regulatory teams, provide feedback and coaching, and support the growth and development of subteam members
- Manage regulatory submissions, portfolio transformation activities, and business and operational excellence tasks
Requirements
- Bachelor's or Master's in a science-based field; advanced degrees preferred
- Fluent in English; additional languages are a plus
- Significant experience in regulatory and pharmaceutical development (Phases I-IV)
- Expertise in regulatory strategy, scientific data analysis, and HA guidance
- Significant experience with major submissions
- Knowledge of post-marketing strategies and commercial awareness
- Proven regulatory operations and compliance skills
- Strong leadership and matrix management abilities
- Excellent communication, influencing, and problem-solving skills
- Ability to navigate organizational complexity effectively
Benefits
- Hybrid (12 days per month on-site if living within 50 miles to our London office)
- Remote (if living beyond 50 miles to our London office)
Job title
Job type
Experience level
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Not specified
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