Director of Regulatory Affairs

1 month ago

mountain view, United States The Carolan Group Full time

Job Title: Director/Senior Director of Regulatory Affairs – Global Regulatory Lead (Oncology)


Location: Princeton, NJ OR Mountain View, CA


Overview:

Our client, a leader in innovative drug development, is seeking a strategic and experienced Director or Senior Director of Regulatory Affairs to join their Global Regulatory team. This role involves developing and implementing global regulatory strategies to secure and sustain market approvals across key regions, including the US, EU, Japan, Canada, and Australia. The successful candidate will be a pivotal leader, driving regulatory strategy and compliance in alignment with the company’s goals while providing expert guidance to cross-functional teams.


Key Responsibilities:

  • Global Regulatory Strategy Development: Lead the development of creative and accelerated submission strategies for new and marketed products, ensuring alignment with applicable regulations to achieve business objectives.
  • Team Leadership: Head the Global Regulatory Team, fostering a collaborative and cohesive environment. Act as the primary regulatory point of contact for the product development team and supporting functions.
  • Risk Management: Proactively identify and mitigate regulatory risks, communicating risk assessments and mitigation strategies to relevant stakeholders.
  • Cross-functional Collaboration: Partner with regulatory and cross-functional teams to develop strategic messaging and clear content in global regulatory dossiers and responses to regulatory agencies.
  • Regulatory Compliance: Ensure all global regulatory requirements are met and that submissions align with evolving regulatory reforms and guidance.
  • Policy and Strategy Influence: Analyze global regulations, legislation, and guidance, providing insights and direction to influence internal policies and external regulatory landscapes.
  • Regulatory Leadership: Act as a key internal driver of regulatory policy, strategy, and implementation. Lead or participate in company-wide initiatives related to regulatory processes.

Qualifications:

  • Education: Advanced scientific degree (PhD, MD, PharmD) or master’s degree with at least 10 years of drug development experience. Oncology experience as a Global Regulatory Lead (GRL) is highly preferred.
  • Experience:
  • 10+ years in pharmaceutical regulatory affairs, including experience as a lead regulatory strategist for major regions beyond the US, such as the EU or Japan.
  • Strong global drug development foundation and business acumen.
  • Direct regulatory and leadership experience across multiple regions.
  • Proven track record in regulatory submissions and interactions with agencies in the US, EU, Japan, and China.
  • Expertise in clinical and CMC regulatory sciences with knowledge of evolving regulatory reforms.

Skills and Competencies:

  • Leadership: Demonstrated experience in guiding and mentoring regulatory teams.
  • Strategic Communication: Strong communication skills, including presenting, negotiating, and influencing internal and external stakeholders.
  • Analytical Skills: Ability to analyze regulatory changes and provide actionable insights to support corporate objectives.
  • Attention to Detail: Highly detail-oriented with a focus on regulatory accuracy and compliance.

Additional Preferences:

  • Industry-related experience in regulatory affairs for oncology and other therapeutic areas.
  • Experience in influencing regulatory frameworks and contributing to regulatory guidelines.

This is a unique opportunity for a regulatory professional with a passion for driving global strategies in oncology. If you meet the above requirements and are looking to make an impact, we encourage you to apply and join our client’s mission to advance transformative therapies.

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