Position OverviewAs we prepare for our next stage of growth and clinical advancement, Celea is seeking an experienced, strategic, and hands-on Vice President of Regulatory Affairs to lead our global regulatory strategy and serve as our primary advocate with the FDA and other international health authorities as we advance deupirfenidone (LYT-100) through Phase 3 development toward registration. Reporting to the Chief Medical Officer, this role will be a member of the Celea Leadership Team and will own regulatory strategy, agency interactions, and submissions across all of our development programs while also personally leading the preparation of high-quality regulatory filings - from briefing documents and health authority meetings through the planned NDA/MAA.
In the near term, the focus will be supporting Phase 3 execution and the regulatory interactions and submissions that, together with our Phase 2b results, could serve as the basis for registration in the U.S. and other geographies. Over time, this person will build and scale the regulatory function, establish robust regulatory processes and infrastructure, and help prepare Celea for approval and commercialization, and will be instrumental in guiding Celea through its next chapter.
This position is based in the Greater Boston area, with a hybrid working model.
Key Responsibilities - Lead Celea's Global Regulatory Affairs Function; own the formulation of overall regulatory strategy and tactical plans to achieve the Company's regulatory goals across all programs.
- Oversee all regulatory submissions and interactions from pre-IND through NDA/MAA filings, as well as all filings with health authorities on a global basis.
- Develop trusted, productive relationships with FDA and international health authorities, serving as the Company's primary liaison in agency meetings and negotiations.
- Provide direct regulatory oversight of preclinical, clinical, and CMC activities; review and endorse key development documents, including target labeling, pivotal protocols and study designs, analytical plans, and risk management plans.
- Develop and design robust regulatory structures, processes, and procedures - including thoughtful use of AI and automation - so the function scales with the company.
- Partner cross-functionally with clinical, preclinical, CMC, quality, and commercial teams; provide counsel, training, and interpretation of FDA and other regulatory guidelines to Company personnel.
- Ensure the Company's ongoing compliance with regulatory mandates; be accountable for regulatory inspections and audits, and participate in the review of labeling and promotional materials.
- Propose and lead regulatory advisory boards and consultancies with clear objectives, and support business development and due diligence efforts with regulatory expertise.
- As we grow, recruit, mentor, and develop a high-performing and highly collaborative regulatory team.
Qualifications Required - Bachelor's degree in life sciences or a related scientific discipline; an advanced degree is preferred; equivalent experience considered.
- 15+ years of experience in Regulatory Affairs within the biotech or pharmaceutical industry, including 7+ years of leadership and management experience.
- Demonstrated expertise in leading, designing, writing, and submitting regulatory filings - including successful steering of critical filings (IND, NDA, BLA, MAA) through submission, approval, and life-cycle management.
- Track record of successful global regulatory filings and agency interactions, as demonstrated by timely submissions and approvals with the FDA, EMA, and other regulatory authorities.
- In-depth understanding of drug development, product commercialization, and life-cycle management.
- Excellent oral and written communication skills, with the ability to build cross-functional relationships, influence effectively both internally and externally, and work collaboratively.
- Entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment.
- Proficiency using AI tools to work smarter - curiosity about how technology can improve the quality and speed of your work.
Preferred - Regulatory experience in pulmonology, respiratory, or fibrotic diseases, and a track record of taking programs through Phase 3 toward registration.
- Advanced degree (PhD, PharmD, or MS) or RAC certification, and experience building a regulatory function in a small or growing clinical-stage biotech.
Why Join Celea Therapeutics - Play a pivotal role in advancing life-changing therapies for patients with devastating lung diseases.
- Shape the foundation of a Phase 3-ready biotech poised for significant growth.
- Collaborate with a passionate, mission-driven leadership team.
- Competitive compensation and equity package.
Compensation Transparency is one of our values, and that includes how we pay. The anticipated salary range for this role is $330,000 - $375,000 plus bonus and equity. Where an offer lands within the range reflects the candidate's experience, skills, and internal equity - and we welcome open conversations about compensation from the first call, so there are no surprises at the offer stage.
Actual compensation will be determined based on experience, qualifications, and location. In addition to base pay, this role is eligible for bonus and equity compensation.
Base Pay Information
$330,000-$375,000 USD
