About Restem/BioBox LLC
Restem is a clinical-stage biotechnology company advancing next-generation cell therapies designed to modulate the immune system and treat inflammatory, autoimmune, and age-related diseases. With a passionate team dedicated to restoring health through innovation and a robust pipeline that includes proprietary cellular therapeutics such as Restem-L and activated natural killer (aNK) programs, we are transforming cutting-edge science into life-changing treatments. Restem is headquartered in Miami, FL, with labs and manufacturing facilities in Corona, CA. (Restem)
JOB TITLE: Chief Regulatory Affairs Officer (CRAO)
EMPLOYER: RESTEM Group, Inc.
REPORTS TO: Chief Executive Officer (CEO)
EXECUTIVE LEVEL: C-Suite
POSITION SUMMARY
The Chief Regulatory Affairs Officer (CRAO) will serve as a key member of RESTEM’s executive leadership team, responsible for defining and leading the Company’s global regulatory strategy across its innovative cell-based therapeutic platforms. This role is highly strategic in nature and is designed for a seasoned regulatory leader who brings deep experience, sound judgment, and executive presence to guide regulatory pathways from clinical development through commercialization.
The CRAO will act as the Company’s senior regulatory authority and primary strategic interface with global regulatory agencies, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other international regulators. This leader will advise the CEO, Board of Directors, and executive team on regulatory risk, timelines, and opportunities, enabling efficient development, regulatory alignment, and long-term value creation. The Company is committed to empowering the CRAO with the autonomy, resources, and organizational flexibility required to build a world-class regulatory function.
RESTEM is seeking a regulatory leader who can architect regulatory strategy, anticipate regulatory expectations, and partner closely with internal teams to ensure alignment, while being supported by experienced operational, quality, and clinical teams.
KEY RESPONSIBILITIES
Regulatory Strategy and Executive Leadership
- Define and own RESTEM’s global regulatory strategy across clinical development, CMC, non-clinical programs, and commercialization.
- Provide executive oversight of regulatory planning across product lifecycles, from early development through registration and post-approval activities.
- Advise executive leadership and the Board on regulatory risk, regulatory science considerations, and strategic decision-making.
- Shape regulatory pathways for innovative cell-based and biologic therapies addressing high unmet medical needs.
FDA and Global Regulatory Engagement
- Serve as the Company’s primary strategic liaison with the FDA, EMA, and other global regulatory authorities.
- Lead and participate in key regulatory interactions, including Pre-IND, IND, End-of-Phase, Type A, B, and C meetings, advisory committee engagements, and pre-BLA or pre-NDA discussions.
- Provide strategic oversight for regulatory submissions, including INDs, CTAs, BLAs, NDAs, and lifecycle management activities, in collaboration with internal and external teams.
- Anticipate regulatory expectations and guide internal planning to support efficient and predictable development timelines.
Cross-Functional Partnership
- Partner closely with Clinical, R&D, Manufacturing, Quality, Legal, and Commercial leadership to integrate regulatory considerations into development and business plans.
- Provide executive regulatory guidance related to labeling, promotional strategy, and post-market commitments.
- Support regulatory due diligence for partnerships, licensing opportunities, and strategic transactions.
Oversight of Regulatory and Quality Infrastructure
- Provide executive oversight and strategic alignment of regulatory affairs, quality systems, and compliance functions, in partnership with operational leadership.
- Ensure inspection readiness through strategic governance, rather than day-to-day operational management.
- Guide responses to regulatory inspections, observations, and correspondence at an executive level.
Leadership and Organizational Development
- Build and mentor a high-performing Regulatory Affairs organization as the Company grows.
- Evaluate and evolve the Regulatory Affairs function over time, including the ability to recommend hires and to develop, and scale internal teams and external advisors to support the Company’s evolving pipeline and growth.
- Establish scalable regulatory processes, governance frameworks, and external advisory support as needed.
- Engage and oversee external regulatory consultants and advisors to support execution.
SCOPE AND AUTHORITY
- Executive-level role with direct access to the CEO and Board of Directors.
- Owns global regulatory strategy and regulatory decision frameworks.
- Represents RESTEM externally with regulators, partners, and key stakeholders.
- Signals seniority, credibility, and decision authority to regulators and investors.
- Focused on cell-based and biologic therapeutic platforms.
SKILLS AND QUALIFICATIONS
- Advanced degree required (PhD, PharmD, MD, JD, or MS) in Life Sciences, Regulatory Affairs, Pharmacy, Medicine, or a related field. Deep, hands-on knowledge of FDA regulatory frameworks, CBER processes, and biologics development.
- Strong understanding of global regulatory systems, including EMA and other international authorities.
- Experience guiding clinical development programs through complex regulatory environments.
- Broad familiarity with cGMP, cGCP, cGLP, and quality systems at a strategic oversight level.
- Exceptional regulatory judgment, executive presence, and communication skills.
- Ability to influence cross-functional teams and senior stakeholders.
- High ethical standards and commitment to patient safety and regulatory integrity.
- Strategic mindset with the ability to translate regulatory science into practical business decisions.
ROLE EXPECTATION STATEMENT
This role is designed to focus on regulatory strategy, leadership, and decision-making, with the execution to be supported by experienced internal teams and external partners. The CRAO will define direction, guide teams, and provide executive oversight, while being supported by experienced clinical, quality, and operational functions. RESTEM values regulatory excellence, sound judgment, and partnership, and is committed to providing the resources and organizational support required for success in this role.
If you meet the qualifications and are interested, we look forward to you applying online.
We are an Equal Opportunity Employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other legally protected status. All employment decisions are based on business needs, job requirements, and individual qualifications, in accordance with applicable federal, state, and local laws.
Job Type: Full-time
Pay: $200,000.00 - $225,000.00 per year
Application Question(s):
- What is your desired salary range?
- Which degree(s) have you obtained and in which field(s)?
Work Location: In person
