Regulatory Specialist

Job#: 3056987
Job Description:
Job Description: Global Regulatory Lead / U.S. Regulatory Lead (Cardiovascular Program)
Position Summary
We are seeking an experienced Global Regulatory Lead (GRL) and/or U.S. Regulatory Lead (USRL) to provide strategic regulatory leadership for a late-stage cardiovascular development program. This individual will serve as the primary regulatory lead for a key investigational cardiovascular asset and will drive global regulatory strategies through critical development and registration milestones, including NDA preparation, submission, and review activities.
The ideal candidate will have a strong regulatory background in cardiovascular drug development, extensive experience leading global regulatory strategies, and a proven track record of successful interactions with health authorities.
Pay Rate: 112/hr
Key Responsibilities
Global Regulatory Leadership

• Serve as the Global Regulatory Lead (GRL) and/or U.S. Regulatory Lead (USRL) for a late-stage cardiovascular development program.
• Lead and execute global regulatory strategies that align with development, clinical, and business objectives.
• Provide strategic regulatory leadership throughout major development milestones, including:
  • Database Lock (DBL)
  • NDA preparation
  • NDA submission
  • Regulatory review activities
• Lead and facilitate Global Regulatory Teams (GRTs), driving effective collaboration, decision-making, and execution across internal and external stakeholders.
• Ensure regulatory strategies are integrated across functional teams and global regions.

NDA Submission & Regulatory Strategy

• Drive regulatory readiness and execution for original NDA submissions.
• Provide oversight of global submission activities, including:
  • Integrated submission planning
  • Cross-functional coordination
  • Risk identification and mitigation
  • Submission governance and execution
• Develop product registration strategies and convert them into operational regulatory plans.
• Evaluate alternative regulatory pathways and create risk mitigation strategies to achieve development objectives.
• Lead U.S. regulatory planning and submission activities.

Health Authority Engagement

• Develop and execute global and U.S. health authority engagement strategies.
• Lead interactions with regulatory agencies in partnership with regional and local regulatory teams.
• Serve as the primary regulatory subject matter expert (SME) for agency communications, regulatory risks, and submission approaches.
• Support the preparation of:
  • Briefing documents
  • Regulatory meeting materials
  • Health authority responses
  • Agency correspondence

Cross-Functional Collaboration

• Collaborate with clinical, nonclinical, biostatistics, medical, commercial, and development teams to ensure regulatory considerations are incorporated into program plans.
• Influence internal stakeholders and external partners on strategic regulatory decisions.
• Operate effectively within complex partnership environments, aligning governance, regulatory strategy, and execution plans across organizations.
• Lead resolution of critical regulatory issues through effective stakeholder engagement and expert consultation.

Strategic Regulatory Support
Provide regulatory guidance and input for:

• Clinical Study Protocols
• Clinical Study Reports (CSRs)
• Statistical Analysis Plans (SAPs)
• Nonclinical Reports and Summaries
• Clinical Summary Documents
• NDA and other global regulatory submissions

Contribute to the development of:

• Target Product Profiles (TPPs)
• Company Core Data Sheets (CCDS)
• U.S. labeling strategies
• Global labeling strategies
• Country-specific labeling requirements

Required Qualifications

• PhD, MD, PharmD, MS, or BS in a relevant scientific discipline.
• Significant Regulatory Affairs experience (typically 4-7+ years, preferably more in a leadership capacity).
• Prior experience supporting cardiovascular drug development programs.
• Experience serving as:
  • Global Regulatory Lead (GRL), and/or
  • U.S. Regulatory Lead (USRL)
• Demonstrated experience leading major regulatory submissions and health authority interactions.

Preferred Qualifications

• Proven success developing and implementing global regulatory strategies that support clinical development and successful product registration.
• Strong understanding of global regulatory requirements and submission processes.
• Experience communicating regulatory strategy, risks, and recommendations to executive and senior leadership.
• Demonstrated ability to lead large, complex matrix teams across functions and geographies.
• Ability to translate complex scientific and regulatory issues into actionable business recommendations.
• Successful track record negotiating regulatory objectives with global health authorities.
• Experience managing regulatory activities in collaborative or partnership-driven development environments.

Key Competencies

• Strategic Thinking
• Regulatory Leadership
• Health Authority Negotiation
• Cross-Functional Influence
• Risk Assessment & Mitigation
• Submission Planning & Execution
• Stakeholder Management
• Executive Communication
• Global Team Leadership
• Decision Making in Complex Environments

Industry: Pharmaceuticals / Biotechnology
Function: Regulatory Affairs
Therapeutic Area: Cardiovascular
Employment Type: Contract / Full-Time (as applicable)
Experience Level: Senior Director / Executive Director equivalent experience preferred for late-stage development leadership roles.
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