Secretome Therapeutics · 21 hours ago
Regulatory Affairs, Senior Director/VP
Dallas, TX
Full-time
Onsite
Director/Executive
10+ years expSecretome Therapeutics is a clinical-stage cell therapy company focused on developing innovative therapies for serious cardiovascular and neuromuscular diseases. They are seeking a Regulatory Affairs professional to lead and execute global regulatory strategy across their pipeline of cell and stem-cell–based therapies, serving as a strategic partner to various departments and ensuring regulatory compliance throughout the development process.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Advise the head of CMC and help lead the CMC regulatory strategy for cell and stem cell therapy programs from pre-IND through late-stage development and registration
Serve as regulatory lead for interactions with FDA (CBER), EMA, and other global health authorities
Drive regulatory pathways for rare diseases, including Orphan Drug Designation, RMAT, Fast Track, Breakthrough Therapy, and PRIME as appropriate
Lead and participate in FDA and EMA meetings (pre-IND, INTERACT, Type B/C, Scientific Advice, EOP)
Prepare briefing documents, regulatory position papers, and responses to agency questions
Act as primary regulatory point of contact with global regulatory agencies
Provide regulatory guidance on clinical trial design, endpoints, biomarkers, and pediatric development plans
Partner closely with Clinical, CMC, Nonclinical, and Quality to ensure regulatory alignment across functions
Oversee preparation and submission of INDs, CTAs, amendments, annual reports, and marketing applications
Provide regulatory leadership specific to cell therapy, stem cell therapy, and biologics manufacturing
Advise on CMC strategy for cell-based products, including comparability, potency assays, and lifecycle management
Ensure compliance with evolving regulatory frameworks for ATMPs in the US and EU
Represent Regulatory Affairs on internal development teams and governance committees
Mentor and build regulatory capability as the organization grows
Contribute to investor, board, and partner communications as needed
Qualification
Required
Advanced degree (PhD, MD, PharmD, or equivalent) in life sciences or related field
10+ years of CMC / regulatory affairs experience in biotech or pharma (flexible based on level)
Significant experience with cell therapy and/or stem cell therapy
Hands-on experience across multiple development phases (preclinical through late-stage)
Direct experience interacting with FDA and EMA
Strong understanding of US and EU regulatory frameworks for biologics and advanced therapies
Preferred
Experience in cardiology and/or neurology
Experience in rare diseases
Prior experience with Duchenne muscular dystrophy (DMD) and/or DMD-associated cardiomyopathy
Experience supporting Orphan, RMAT, PRIME, or Accelerated Approval pathways
Prior leadership in a small or emerging biotech environment
Benefits
Competitive compensation
Equity participation
Growth potential
Company
Secretome Therapeutics
Secretome Therapeutics specializes in the research and development of neonatal mesenchymal stem cells for the treatment of disease.
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$29.05MKey Investors
HEST
2024-11-25Undisclosed· $20.4M
2024-08-09Series Unknown· $1.8M
2023-02-02Series Unknown· $6.85M
Recent News
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