Insight
Director of Regulatory Affairs
Get notified of more jobs like this · No spam, ever
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Company Description
Insight delivers AI-driven pharmaceutical intelligence that supports drug research and development with real-time data and analytics. The platform provides detailed information on compounds, clinical trials, disease profiles, drug targets, and regulatory insights to help teams assess safety, effectiveness, and market potential. By centralizing critical pharmaceutical information, Insight enables researchers, clinicians, and regulatory professionals to make faster, more informed decisions. The company focuses on improving the efficiency and quality of drug development through advanced technology and data-driven intelligence. Insight’s solutions help organizations reduce risk, streamline processes, and uncover new development opportunities.
Role Description
The Director of Regulatory Affairs is a full-time, remote role responsible for leading regulatory strategy and oversight across Insight’s products and services. This role includes:
- Developing and implementing global regulatory plans
- Ensuring compliance with relevant regulatory requirements
- Guiding teams on the implications of evolving regulations in drug development and pharmaceutical intelligence
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
Day-to-day responsibilities involve:
Get help with your application
Your very own career expert that helps elevate your application to the next level.
- Preparing, reviewing, and coordinating regulatory submissions
- Collaborating with cross-functional teams such as product, clinical, data, and legal
- Serving as the primary regulatory point of contact for internal and external stakeholders
The Director will:
- Monitor regulatory trends
- Maintain regulatory intelligence within the organization
- Contribute to product design and documentation to support appropriate approvals and adherence to standards
This position also includes:
- Mentoring team members
- Improving regulatory processes
- Supporting strategic partnerships and client engagements from a regulatory perspective
Qualifications
- Demonstrated expertise in Regulatory Affairs, including hands-on experience with Regulatory Requirements and Regulatory Intelligence in the pharmaceutical or biotech industry.
- Proven ability to develop and execute Regulatory Strategy, aligning regulatory plans with business goals and product roadmaps.
- Experience leading and managing Regulatory Submissions (e.g., INDs, NDAs, BLAs, MAAs or equivalent), including preparation, review, and interaction with regulatory authorities.
- Strong Cross-functional Team Leadership skills, with a track record of collaborating effectively with clinical, R&D, product, data science, and legal teams.
- Advanced understanding of global regulatory frameworks and guidelines (e.g., FDA, EMA, ICH) and experience interpreting and applying them to innovative technologies or data platforms.
- Excellent analytical, written, and verbal communication skills, including the ability to translate complex regulatory concepts into clear guidance for diverse audiences.
- Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree (e.g., MS, PharmD, PhD, JD) is preferred.
- Prior leadership experience in a regulatory function, with responsibility for strategy, team mentoring, and stakeholder engagement.
- Ability to work effectively in a remote, fast-paced environment, manage multiple priorities, and maintain high attention to detail.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Location