Associate Director/Director, Regulatory Affairs

Belenos Biosciences Inc.; New York (NY); Remote; USD 180,000 - 240,000; Full time

Job summary

Belenos Biosciences Inc. is seeking a Director/Associate Director, Regulatory Affairs for a remote role in the United States (EST). This hands-on leadership position focuses on regulatory strategy, submissions, and cross-functional collaboration to advance therapeutic programs.

You will lead IND and BLA submissions, guide regulatory planning, and interact with FDA and other authorities, while mentoring teams and ensuring timely, high-quality deliverables across EU and APAC activities.

Qualifications

• BS degree in a scientific discipline; advanced degree is required.
• 8+ years in Regulatory Affairs within biotech/pharma.
• Hands-on experience leading US IND and BLA submissions.
• Strong knowledge of US regulatory requirements and FDA interactions.
• Global regulatory experience including EU and APAC regions.
• Experience developing regulatory strategies across multiple development stages.
• Experience supervising regulatory vendors and CROs.

Responsibilities

• Develop and execute global regulatory strategies aligned with development goals.
• Lead regulatory submissions (IND, BLA, CTA, MAA) and milestones.
• Coordinate regulatory documentation and ensure high-quality deliverables.
• Lead interactions with FDA and other health authorities; develop meeting packages.
• Provide regulatory input to clinical development plans and labeling strategies.
• Collaborate with cross-functional teams to ensure regulatory compliance.

Skills

Regulatory strategy

Regulatory leadership

Cross-functional collaboration

FDA interactions

Education

Bachelor's degree in a scientific discipline

Advanced degree (PhD, PharmD, MS, or equivalent)

Job description

Position: Associate Director/Director, Regulatory Affairs

Location: Remote — United States, EST TIME ZONE

Reports to: Senior Vice President, Head of Regulatory Affairs

Position Summary

We are seeking a highly motivated and experienced Director/Associate Director, Regulatory Affairs to join Belenos Biosciences, a growing biotech organization. This is a highly visible, hands-on role for a regulatory professional who thrives in a dynamic, entrepreneurial environment and enjoys working across functions to advance innovative therapeutics. The successful candidate will serve as a regulatory project manager, strategist, and trusted subject-matter expert, providing regulatory leadership and guidance across the organization. This individual will be a key point of contact for regulatory planning, submissions, and day-to-day regulatory questions across clinical development activities. Reporting to the SVP, Head of Regulatory Affairs, the individual will work closely with Clinical Development, Clinical Operations, Biometrics, Nonclinical, Safety, Quality, and other cross-functional teams. The candidate should have strong hands-on expertise with US IND and BLA submissions, global regulatory strategy, and health authority interactions, with particular experience in European and APAC regulatory environments.

Key Responsibilities

• Make key contribution to develop and execute global regulatory strategies aligned with overall development and business objectives.
• Provide regulatory strategic guidance across the product lifecycle, from early development through registration.
• Lead the regulatory submission according to health authority guidance and company defined strategies and standards (including IND, BLA, CTA, and MAA).
• Ensures all internal and external due dates for regulatory milestones are well planned, tracked and met with quality deliverables.
• Identify regulatory opportunities, risks, and potential development or submission challenges and proactively develop mitigation strategies.
• Translate complex regulatory requirements into innovative, clear, practical recommendations for internal stakeholders.
• Lead and coordinate regulatory activities across assigned projects, serving as the regulatory project manager and central point of accountability.
• Develop regulatory plans, timelines, milestones, and submission strategies in collaboration with cross-functional teams.
• Coordinate preparation, review, and submission of regulatory documentation and ensure high-quality, timely deliverables.
• Lead or contribute to IND and BLA submissions, including strategy development, submission planning, document coordination, and responses to FDA questions.
• Lead and/or support regulatory assessment of clinical, nonclinical, safety, and labeling strategies.
• Provide regulatory input into clinical development plans, protocols, investigator materials, and other development documents.
• Provide regulatory guidance for submissions and development activities in the EU and key APAC regions.
• Lead and/or support interactions with FDA and other health authorities and drive cross-functional team for preparation of meeting packages and responses. Develop meeting strategies, agendas, briefing packages, questions, and responses in collaboration with cross-functional teams.
• Partner with Quality and other functions on regulatory compliance and inspection readiness activities.

Other responsibilities might be assigned based on business need

Qualifications:

• BS degree in a scientific discipline. Advanced degree is required in a relevant scientific, medical, pharmacy, regulatory, or related discipline (e.g., PhD, PharmD, MS, or equivalent).
• 8+ years of progressive Regulatory Affairs experience within the biotechnology and/or pharmaceutical industry.
• Demonstrated recent successful hands-on experience leading or substantially contributing to US IND and BLA submissions.
• Strong knowledge of US regulatory requirements and experience interacting with the FDA.
• Demonstrated global regulatory experience, including experience with regulatory requirements and pathways in the EU and APAC regions.
• Experience developing and implementing regulatory strategies across multiple stages of drug development.
• Experience supervising and working with regulatory vendor and CROs.
• Demonstrated ability to lead regulatory activities in a cross-functional, matrixed environment.
• Strong regulatory project management skills, including the ability to manage timelines, dependencies, priorities, and multiple workstreams.