Director, Regulatory Affairs

Kaléo; Richmond (VA); Remote; USD 130,000 - 160,000; Full time

Job summary

A leading company in drug-delivery technology is seeking a Director of Regulatory Affairs to oversee regulatory strategies and compliance for new product development. This role involves collaboration with regulatory bodies and managing nonclinical work, emphasizing a remote-first culture.

Qualifications

• At least 8 years in pharmaceutical, biotech, or medical device industries.
• At least 5 years in regulatory affairs, with 3 years managing areas independently.

Responsibilities

• Lead regulatory proposals and evaluations for compliance and accelerated pathways.
• Manage consultants, CROs, budgets, and study execution.
• Prepare and lead regulatory meetings and submissions, including INDs, NDAs.

Skills

Leadership

Strategic Thinking

Analytical Skills

Communication

Education

Degree in a scientific discipline

Job description

Join to apply for the Director, Regulatory Affairs role at Kaléo

Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients and emergency responders with security and peace of mind. Kaléo has secured multiple contracts with the U.S. government for medical countermeasures, with commercialization opportunities to follow. The Director, Regulatory Affairs will focus on new product development programs and oversee nonclinical work by vendors and CROs. This role reports to the head of Regulatory Affairs and collaborates closely with Kaléo's Chief Development Officer.

Responsibilities include strategic leadership in regulatory affairs, pre-market regulatory strategy and compliance, and interaction with external regulatory bodies such as the FDA, U.S. Department of Defense, and regulatory CROs/consultants. The Director will serve as a regulatory SME on investigational programs and oversee nonclinical development, including managing vendors, assessing risks, and FDA approval strategies.

At Kaléo, you will manage assets within the development portfolio, working across regulatory and nonclinical issues for both drug and device regulations. The company promotes a remote-first culture, emphasizing flexibility, self-management, and impactful work.

Key Responsibilities

1. Regulatory Strategy
   • Stay informed of new regulatory requirements and communicate them to the team.
   • Develop and implement regulatory strategies across development phases.
   • Manage program plans, roles, responsibilities, and timelines.
   • Lead regulatory proposals and evaluations for compliance and accelerated pathways.
2. Regulatory Affairs
   • Lead interactions with regulatory agencies, partners, and vendors.
   • Prepare and lead regulatory meetings and submissions, including INDs, NDAs, and reports.
   • Review development plans and ensure compliance with regulations.
   • Advise on international product registration and import/export requirements.
3. Nonclinical
   • Identify study requirements and develop nonclinical strategies.
   • Manage consultants, CROs, budgets, and study execution.
   • Review protocols and reports, ensuring compliance.

Qualifications for Success

• Attention to detail and commitment to flawless regulatory submissions.
• Leadership skills, strategic thinking, and team motivation abilities.
• Ability to thrive in a fast-paced environment and manage priorities.
• Strong analytical and communication skills.
• Curiosity and commitment to innovation and inclusivity.

Minimum Requirements

• Degree in a scientific discipline.
• At least 8 years in pharmaceutical, biotech, or medical device industries.
• At least 5 years in regulatory affairs, with 3 years managing areas independently.
• Experience with regulatory submissions, including electronic submissions in the U.S.
• Experience across all development stages from pre-clinical to post-marketing.
• Ability to travel up to 25%.
• Proven collaboration with regulatory agencies like the FDA.

Preferred Qualifications

• Advanced degree (PhD preferred).
• Regulatory Affairs Certification.
• Experience with drug/device combination products.
• Experience with government contracts.

Application required. Contact [e-mail] for questions.