[Hiring] Senior Manager, Global Regulatory Strategy @AMER

Role Description

The Senior Manager, Global Regulatory Strategy oversees regulatory activities for the assigned early-stage portfolio across global markets. Reporting to the VP, Global Regulatory Strategy, this individual-contributor role executes the global regulatory strategy for assigned assets, planning and delivering high-quality submissions from IND/CTA through to early registration. As a key contributor to the Regulatory Strategy team, the Senior Manager provides regulatory expertise for early-stage programs, prepares health authority interactions, and supports the VP on global regulatory planning and cross-functional initiatives that accelerate development.

Key Accountabilities:

• Regulatory Strategy & Planning:
  • Contribute to and execute the global regulatory strategy for assigned early-stage assets, planning IND/CTA submissions in collaboration with cross-functional teams and under the direction of the VP, Global Regulatory Strategy.
  • Develop submission plans, timelines, and content requirements for assigned programs, ensuring alignment with development milestones and corporate objectives.
  • Support the development of registration strategies and manage the registration process for assigned early-stage assets in collaboration with cross-functional teams.
• Health Authority Interactions:
  • Prepare briefing packages and supporting materials for health authority meetings on early-stage filings; draft meeting minutes and responses to agency questions with senior review.
  • Interface with FDA, EMA, TGA, PMDA, and other health authorities for assigned filings, ensuring submissions meet regulatory requirements and deadlines.
• Cross-Functional Collaboration:
  • Partner with QA, Clinical Development, Research & Innovation, and other functions to assemble compliant, on-time dossiers for assigned assets.
  • Provide regulatory guidance to project teams on assigned early-stage programs.
• Risk Management & Compliance:
  • Identify regulatory risks on assigned programs and recommend mitigation plans to the VP, Global Regulatory Strategy.
  • Monitor evolving global health authority regulations and guidelines, maintaining submission compliance for assigned assets.
  • Manage responses to health authority queries, variations, and post-approval requirements for assigned early-stage programs.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred).
• 8+ years of experience in Regulatory Affairs, with strong early-stage (IND/CTA) submission experience.
• Strong experience in clinical regulatory submissions (CTAs, INDs) and early-stage development.
• Working knowledge of global regulatory frameworks (FDA, EMA, TGA, PMDA, Health Canada, Medsafe).
• Experience preparing for and supporting health authority interactions.
• Strong knowledge of ICH guidelines, CTD/eCTD submissions, and the regulatory lifecycle.

Requirements

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.