Head of Regulatory Affairs
Location: Leuven/Flexible/Remote
Job Type: Full-time
About Us: Onco3R is a dynamic and innovative biotech start-up company committed to transform the lives of patients with autoimmune diseases and cancer. We are seeking a strategic, hands-on Head of Regulatory Affairs to lead and execute our global regulatory strategy across a growing pipeline of innovative therapeutics.
Scope of the job
The Head of Regulatory Affairs is a key member of the development team and will be responsible for developing and implementing regulatory strategies as part of the optimal development of molecules in the Onco3R portfolio. This is an exciting opportunity to shape the regulatory function within a fast-paced, entrepreneurial biotech environment.
The ideal candidate will bring deep regulatory expertise, strong leadership capabilities, and a proven track record of hands on experience in contributing to the development of molecules. Therapeutic area expertise in autoimmune diseases and oncology is not an absolute requirement but it preferred.
Key responsibilities
Regulatory Strategy & Leadership
Develop and execute global regulatory strategies for preclinical and clinical-stage programs across major territories
Serve as the primary regulatory representative on internal project teams and with external stakeholders
Provide regulatory guidance on development plans, study design, endpoints, and labelling
Regulatory Submissions
Lead the preparation and submission of regulatory documents (e.g., INDs/CTAs, amendments, orphan drug applications, Fast Track/Breakthrough Therapy designations)
Manage interactions with global health authorities (e.g., FDA, EMA, MHRA), including pre-IND and scientific advice meetings
Oversee or contribute to regulatory aspects of investigator brochures, protocols, and clinical study reports
Compliance & Quality
Ensure compliance with applicable regulatory requirements throughout development
Support the establishment and maintenance of regulatory procedures and internal systems
Monitor changes in global regulatory requirements and communicate relevant updates internally
Cross-Functional Collaboration
Collaborate closely with clinical, CMC, nonclinical, quality, and commercial teams
Provide regulatory input into due diligence, partnerships, and investor communications as needed
Job requirements
Advanced degree in a life science discipline (PhD, PharmD, or MSc preferred)
15+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry
Proven track record of leading global regulatory submissions (INDs/CTAs and early development interactions with agencies)
Experience oncology or immunology is a strong plus
Ability to operate both strategically and tactically in a resource-constrained, fast-paced environment
Strong interpersonal and communication skills, with the ability to influence internal and external stakeholders
Benefits
Competitive salary and benefits package.
Opportunity to work in a fast-paced and innovative environment.
Opportunity to help shape the growth of the company.
How to Apply
Interested candidates should submit their resume and cover letter to contact@onco3R.com