Director, Regulatory Affairs (Biotech)

Location: Hybrid; Thousand Oaks, the San Francisco Bay Area, or the Washington, D.C. area

Company

hirify.global develops therapeutic programs requiring global regulatory strategy and clinical development support.

What you will do

• Lead and implement regulatory strategies supporting product development programs.
• Support interactions with FDA, EMA, MHRA, and other global health authorities.
• Provide regulatory input into clinical development plans, study designs, labeling strategies, protocols, and statistical analysis plans.
• Oversee preparation, review, and submission of INDs, CTAs, NDAs, briefing documents, and related regulatory materials.
• Manage regulatory meeting requests and briefing documents for FDA Type B/C meetings and equivalent international interactions.
• Partner with Clinical Development, CMC, Nonclinical, Quality, and leadership teams while identifying regulatory risks and contingency plans.

Requirements

• Bachelor’s, Master’s, PharmD, or PhD, preferably in life sciences.
• At least 8 years of regulatory affairs experience, including direct experience leading or supporting FDA interactions.
• Experience overseeing regulatory activities from research and discovery through clinical development and commercialization planning.
• Experience with IND submission and maintenance; US registration experience is ideal.
• Knowledge of US regulatory procedures; familiarity with EU CTA/MAA processes is preferred.
• Excellent written and verbal communication, analytical and problem-solving skills, and strong attention to detail.

Nice to have

• Experience with small molecules and pain or a similar therapeutic area.
• Regulatory project management experience.
• Experience with fast-to-market regulatory procedures.

Culture & Benefits

• Cross-functional collaboration across clinical, CMC, nonclinical, quality, and leadership teams.
• Hybrid work arrangement across specified US locations.