Lumos Pharma · 3 days ago
Senior Manager, Regulatory Affairs
United States
Full-time
Remote
Senior Level
5+ years expLumos Pharma is a clinical-stage biopharmaceutical company focused on developing new therapies for rare diseases. The Senior Manager, Regulatory Affairs will provide regulatory expertise, manage global regulatory activities, and collaborate with cross-functional teams to ensure the successful execution of regulatory plans.
BiopharmaBiotechnologyClinical TrialsHealth CarePharmaceutical
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
Qualification
Required
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
Benefits
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
Company
Lumos Pharma
Lumos Pharma is a biopharmaceutical company that develops a novel treatment for the rare disease Creatine Transporter Deficiency.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$53.5MKey Investors
Deerfield
2024-10-22Acquired
2020-03-19IPO
2016-04-06Series B· $34M
Leadership Team
John McKew
Chief Operating Officer
Bob Davis
VP, Clinical Operations at Lumos-Pharma
Recent News
Google Patent
2025-05-05
Google Patent
2025-05-05
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