Senior Manager, Regulatory Affairs

Accountabilities:

• • Lead and coordinate regulatory activities for assigned development projects across clinical, non-clinical, and CMC functions, ensuring milestones and submissions are delivered accurately and on schedule.
  • Develop and implement regulatory strategies and tactics designed to support the earliest possible approvals and clearances for assigned products.
  • Manage the preparation, writing, assembly, review, and submission of regulatory dossiers for investigational and registered products in the United States and applicable international markets.
  • Lead preparation and submission of INDs, amendments, BLAs/NDAs, supplements, annual reports, safety reports, and other regulatory documentation.
  • Prepare and manage regulatory meeting requests and briefing packages, ensuring materials are complete, consistent, and aligned with regulatory strategy.
  • Represent Regulatory Affairs on cross-functional project teams, providing regulatory expertise, guidance, and recommendations to support development and business objectives.
  • Maintain regulatory submissions and archives in accordance with applicable requirements and internal procedures.
  • Monitor regulatory developments and communicate significant changes, risks, and opportunities to relevant stakeholders and management.
  • Work effectively with external regulatory consultants, CROs, and other partners when required.
  • Support continuous improvement of regulatory processes while maintaining a strong focus on compliance, quality, and timely execution.

  Requirements

  • Bachelor’s degree in a relevant discipline, with 7+ years of related regulatory affairs experience; equivalent professional experience may be considered.
  • Demonstrated experience preparing and managing IND submissions, including amendments and supporting documentation; NDA experience is strongly preferred.
  • Strong knowledge of CTD/eCTD structures and regulatory submission processes, including experience publishing documents using Adobe Acrobat Professional or comparable tools.
  • Working knowledge of FDA regulations and guidance, as well as applicable ICH requirements; familiarity with regulatory frameworks in other regions is a plus.
  • Solid understanding of GMP, GLP, and GCP requirements and the pharmaceutical product development lifecycle.
  • Strong ability to coordinate complex, cross-functional regulatory projects involving multiple technical disciplines and stakeholders.
  • Excellent written and verbal communication skills, with the ability to translate complex regulatory matters into clear recommendations and action plans.
  • Superior planning, organization, prioritization, and attention-to-detail skills, with the ability to manage multiple deadlines and responsibilities with minimal supervision.
  • Self-motivated and proactive, with sound judgment and the ability to operate effectively in an entrepreneurial, fast-paced environment.
  • Demonstrated analytical thinking, initiative, adaptability, continuous-learning mindset, and results orientation.
  • Collaborative leadership style with the ability to build productive relationships, provide clear feedback, embrace change, and communicate effectively across teams.
  • The role does not include direct supervisory responsibilities.

  Benefits

  • Annual base salary: $139,800–$184,800, with final compensation determined based on factors such as experience, skills, education, certifications, and work location.
  • Eligibility for an annual bonus plan for non-commercial roles.
  • Eligibility for discretionary equity awards and participation in an Employee Stock Purchase Plan.
  • Comprehensive medical, dental, and vision insurance.
  • 401(k) retirement plan.
  • FSA/HSA options.
  • Life insurance coverage.
  • Paid time off and wellness programs.
  • Remote work arrangement within the United States.
  • Opportunity to work in a collaborative, international environment focused on advancing innovative oncology treatments and improving patient access.
  • Commitment to an inclusive workplace where collaboration, continuous learning, bold thinking, and patient focus are valued.