Senior Manager, Regulatory Affairs

Lumos Pharma: Mission & Strategy

Lumos Pharma is a clinical-stage biopharmaceutical company with a mission to develop new therapies for people with rare diseases, prioritizing its focus on conditions where the medical need is high and the pathophysiology is well understood. We are committed to this mission and a strategy that is grounded in time- and cost-efficient drug development, delivering safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs.

This Senior Manager, Regulatory Affairs role will be a critical part of Lumos Pharma’s clinical-stage programs by providing regulatory expertise. As a key member of the development team, you will collaborate with cross-functional teams to manage and support global regulatory activities. Reporting to the Vice President, Regulatory Affairs, you will be responsible for participating in functional team meetings, preparing regulatory submissions, supporting interactions with Health Authorities, and ensuring the successful execution of regulatory plans.

Key Responsibilities

• Represent Regulatory Affairs for assigned programs, providing regulatory guidance, identifying regulatory risks and developing mitigation strategies, and supporting the execution of regulatory plans.
• Support the development and implementation of regulatory strategies for assigned programs, aligning with corporate objectives and regulatory requirements.
• Conduct regulatory research to provide recommendations for various regulatory scenarios, proactively identify risks, and inform regulatory strategies.
• Plan and manage regulatory activities across clinical, nonclinical, and CMC functions to enable the timely and efficient advancement of programs.
• Prepare and maintain regulatory submissions, including INDs/CTAs, periodic reports, expedited program requests, and Health Authority responses.
• Contribute to the preparation of key documents, including clinical protocols, statistical analysis plans, and clinical/nonclinical study reports, by providing regulatory review and ensuring alignment with regulatory expectations.
• Support the planning, preparation, and execution of Health Authority interactions by contributing to meeting strategy, drafting briefing documents, and coordinating responses.
• Collaborate with cross-functional teams and external partners to ensure regulatory deliverables are high-quality and aligned with development timelines.
• Contribute to the development and continuous improvement of Regulatory Affairs processes to support compliance and operational efficiency.

Qualifications

• Bachelor’s degree required, advanced degree in life sciences a plus.
• 5+ years or equivalent relevant experience in regulatory affairs in the biopharmaceutical industry.
• Strong understanding of ICH guidelines and US/EU regulatory requirements, with experience supporting global regulatory filings.
• Hands-on experience preparing and managing IND/CTAs and related submissions required; NDA, MAA, or 510K experience a plus.
• Ability to manage multiple projects in a fast-paced environment, proactively identifying challenges and collaborating cross-functionally to develop solutions.
• Strong organizational and communication skills, with the ability to clearly convey regulatory concepts to cross-functional teams.
• Comfortable working in a dynamic, small-company environment with broad responsibilities and evolving priorities.

Work Environment

This position is remote in the United States.

Travel Expectation

Periodic travel to study sites, investigators, vendors, or team meetings is estimated at up to 15 percent.

What you can expect as a Lumosian

• Industry-competitive compensation
• Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance. Lumos covers 85–95% of the medical premium; all other benefits are company-paid.
• Health Reimbursement Arrangement
• 8 weeks of fully paid parental leave for all new parents
• Gym or fitness class reimbursement
• 401(k) with 5% employer contribution
• Flexible work hours and location
• Generous PTO policy
• 11 paid holidays in the US
• Offices in Austin, TX and Ames, IA

Learn more here