Associate Director, Regulatory Affairs

TL;DR

Associate Director, Regulatory Affairs: Leading regulatory strategy and submission management for oncology assets with an accent on FDA compliance and cross-functional collaboration. Focus on planning and executing IND/NDA submissions, managing agency interactions, and ensuring global regulatory alignment for commercial-stage products.

Location: Remote (US). Preference for candidates based in the Boston area.

Salary: $190,000–$200,000 per year

Company

hirify.global is a biopharmaceutical company developing novel therapeutic candidates to address unmet needs in oncology.

What you will do

• Serve as the primary regulatory representative for drug development project teams.
• Manage the planning, coordination, and preparation of regulatory submissions including INDs, NDAs, and CTAs.
• Lead direct interactions and communications with regulatory agencies.
• Interpret and communicate regulatory expectations to internal and external stakeholders.
• Contribute to pharmacovigilance activities and ensure compliance with applicable regulations.

Requirements

• Bachelor or Master’s degree in a relevant field.
• Minimum 10 years of experience in drug development or regulatory affairs within the biopharmaceutical industry.
• Deep knowledge of FDA regulations is required.
• Proficiency with eCTD and e-publishing systems.
• Strong authoring and content editing skills for regulatory submissions.
• Ability to travel domestically and internationally up to 10%.

Nice to have

• Experience with marketing applications outside the US (e.g., MAA, NDS).
• Experience supporting global clinical studies.

Culture & Benefits

• Competitive base salary, annual performance-based bonus, and equity plans.
• Unlimited vacation policy and 10 annual sick days.
• Comprehensive medical, dental, and vision coverage.
• 401K plan with company matching.
• Collaborative, fast-paced environment focused on oncology innovation.