Immatics

Director, Clinical Regulatory Affairs

Immatics

full-time

Posted on:

Location Type: Remote

Location: Texas • United States

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Salary

💰 $221,000 - $253,830 per year

Job Level

Lead

About the role

  • Develop, own, and continuously refine US clinical regulatory strategy aligned with global development plans and corporate objectives
  • Serve as Regulatory Functional Lead for assigned US clinical programs, ensuring regulatory considerations are embedded in development decisions
  • Lead preparation, strategy development, and execution of FDA interactions (e.g., INTERACT, pre-IND, Type B/C meetings, End-of-Phase meetings, pre-BLA meetings), including briefing document strategy and meeting facilitation
  • Oversee and provide strategic direction for preparation and submission of INDs, amendments, annual reports, and future BLAs, ensuring scientific rigor and regulatory compliance
  • Proactively identify regulatory risks and design mitigation strategies; escalate critical strategic issues only after evaluation of proposed solutions
  • Ensure timely and high-quality responses to FDA requests for information and regulatory feedback
  • Provide program-level regulatory updates, strategic assessments, and recommendations to senior management
  • Drive cross-functional alignment across Clinical, CMC, Nonclinical, Regulatory Operations, and Commercial stakeholders
  • Monitor and assess regulatory landscape and evolving FDA guidance relevant to cell and gene therapy products; translate intelligence into strategic recommendations
  • Ensure regulatory timelines, deliverables, and submission milestones are achieved without need for day-to-day oversight
  • Contribute to development of departmental standards, best practices, and strategic regulatory frameworks
  • Model and promote a solution-oriented mindset within cross-functional teams

Requirements

  • Master’s degree or higher in a scientific or similar discipline
  • 10+ years of regulatory affairs experience
  • Demonstrated experience independently leading FDA interactions
  • Experience developing regulatory strategy for complex clinical programs
  • Ability to lead and execute self-sustainably with minimal supervision
  • Strong strategic thinking and risk assessment capabilities
  • Demonstrated ability to influence cross-functional stakeholders without formal authority.
Benefits
  • Competitive rates for Health, Dental, and Vision Insurance
  • 4 weeks of Paid Time Off, granted up front each year and prorated for first and last year of employment.
  • Sick Time – 7 days (56 hours)
  • 12 Paid Holidays
  • 100% Employer-Paid Life Insurance up to 1x annual salary
  • 100% Employer Paid Short- and Long-Term Disability Coverage
  • 401(k) with Immediate Eligibility & company match…
  • Eligible for 401(k) plan participation as of your first paycheck
  • The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment
  • Partially paid Parental Leave for eligible employees (3 weeks)
  • Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness
  • Employee Paid Identity Theft Protection and Pet Insurance
  • Company provided learning and development opportunities
  • Fast paced, high demand, collaborative and dynamic environment.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategy developmentFDA interactionsIND preparationBLA submissionregulatory compliancerisk assessmentstrategic directionclinical regulatory affairsscientific rigorcross-functional alignment
Soft Skills
strategic thinkinginfluence without authoritysolution-oriented mindsetprogram-level updatescommunicationleadershipproblem-solvingcollaborationdecision-makingstakeholder management
Certifications
Master’s degree