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Principal Consultant
hace 2 meses
STRAGO Healthcare is a global consultancy that provides top-tier talent services to leading Healthcare and Life Sciences organizations worldwide.
With an in-depth understanding of the distinctive challenges and opportunities inherent in each industry, we specialize in sourcing top-tier professionals who are catalysts for innovation, drive improvements in patient outcomes, and shape the future of healthcare.
Job Overview: We are seeking a highly experienced Principal Consultant - Clinical to provide expert strategic advice on clinical and regulatory matters for global drug development projects.
In this role, you will serve as a key leader, working closely with project teams to guide clinical development and regulatory strategies.
Your ability to navigate complex global regulatory environments and shape comprehensive development plans will be instrumental in driving successful project outcomes.
Key Responsibilities: Strategic Regulatory Guidance: Provide strategic regulatory advice and support to project teams, ensuring alignment with global regulatory requirements, timelines, and best practices.
Clinical Development Oversight: Oversee all clinical development activities, ensuring that clinical strategies are aligned with overall project goals and regulatory expectations.
Global Regulatory Planning: Develop and execute a comprehensive global regulatory plan, including submission timelines, regulatory milestones, and risk mitigation strategies.
Agency Interaction Leadership: Lead the development and implementation of the global agency interaction strategy, managing relationships with key regulatory bodies (e.g., FDA, EMA) and ensuring effective communication and submissions.
Cross-functional Collaboration: Collaborate with internal and external stakeholders, including clinical operations, medical affairs, regulatory affairs, and project management, to ensure cohesive execution of clinical development strategies.
Regulatory Submission Expertise: Drive the preparation, review, and submission of clinical documentation (e.g., IND, NDA, MAA) to regulatory agencies, ensuring accuracy and compliance with local and international guidelines.
Risk Management: Identify potential regulatory and clinical risks and develop proactive strategies to mitigate them throughout the drug development lifecycle.
Mentorship and Leadership: Provide leadership and mentoring to junior team members and other stakeholders involved in clinical and regulatory processes, fostering a culture of knowledge sharing and continuous improvement.
Stay Updated on Industry Trends: Monitor changes in global regulatory landscapes, assess their impact on current and future projects, and adjust strategies accordingly to maintain compliance and competitive advantage.
Qualifications: Advanced degree (M.D., Ph.D., or Pharm.D.)
in Life Sciences, Clinical Research, or a related field.
Minimum of 10+ years of experience in clinical development and global regulatory affairs, with a track record of successful regulatory submissions and approvals.
In-depth knowledge of regulatory processes and guidelines (FDA, EMA, ICH) and their application to clinical development.
Proven ability to develop and implement global regulatory strategies in complex clinical programs.
Strong leadership, communication, and interpersonal skills with a demonstrated ability to lead cross-functional teams.
Expertise in managing regulatory agency interactions and submissions.
Exceptional problem-solving skills and ability to manage risk in a highly regulated environment.
Strong organizational skills and the ability to manage multiple projects simultaneously.
Willingness to travel as needed.
