What are the responsibilities and job description for the Head of Regulatory Affairs position at GQR?
About the Opportunity
An innovative neuropsychology company is seeking an experienced and strategic regulatory leader to join a growing biotechnology organization advancing innovative therapies for patients with significant unmet medical needs. This individual will play a key role in shaping regulatory strategy, guiding health authority interactions, and partnering with cross-functional teams to support clinical development programs.
This is an exciting opportunity for a hands-on leader who thrives in a collaborative, fast-paced environment and is passionate about bringing new therapies to patients.
What You'll Do
- Lead the development and execution of global regulatory strategies across clinical-stage programs.
- Serve as a key regulatory representative in interactions with health authorities and external stakeholders.
- Provide strategic regulatory guidance on development plans, submission strategies, and regulatory pathways.
- Oversee the preparation, review, and submission of regulatory documents supporting clinical development activities.
- Partner closely with Clinical Development, CMC, Nonclinical, Quality, and other cross-functional teams to ensure alignment and successful execution.
- Monitor emerging regulatory trends and assess potential impacts on development programs.
- Support business development initiatives, due diligence efforts, and other strategic projects as needed.
- Help build and strengthen regulatory processes, capabilities, and best practices within the organization.
What We're Looking For
- Advanced degree in a scientific, healthcare, or related discipline preferred.
- Significant experience in Regulatory Affairs, Regulatory Science, or a related function within the biotechnology or pharmaceutical industry.
- Demonstrated experience developing regulatory strategy and engaging with global health authorities.
- Strong understanding of drug development and regulatory frameworks.
- Proven ability to influence cross-functional teams and drive complex initiatives forward.
- Excellent communication, leadership, and problem-solving skills.
- Comfortable working in a dynamic, entrepreneurial environment where flexibility and collaboration are critical to success.
Why Join Us?
- Opportunity to make a meaningful impact on innovative therapeutic programs.
- Collaborative, science-driven culture.
- Visibility and partnership with senior leadership.
- Competitive compensation, benefits, and career growth opportunities.