Associate Director, Regulatory Affairs CMC (Biopharmaceuticals)

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected.

Salary: $164,000–$213,000 annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Lead CMC regulatory strategy development and implementation for assigned development and post-approval programs in the EMEA region.
• Plan and coordinate regulatory submissions for clinical development, commercial applications, and product lifecycle management.
• Develop CMC background documentation for consultations with the EMA, MHRA, and other regulatory authorities.
• Author CMC sections for IND/IMPD, NDA/MAA, and other regulatory submissions using internal and vendor technical documentation.
• Establish product-specific strategies for early development, registration, and lifecycle management.
• Review and approve CMC change-control documents and interpret applicable regulatory requirements.

Requirements

• Bachelor’s degree or higher.
• 5–7 years of pharmaceutical development and regulatory CMC experience in the biotechnology or pharmaceutical industry.
• Prior experience in a GMP environment and strong understanding of industry regulations and best practices.
• Solid understanding of EU/ICH regulations and country-specific guidelines for small molecules and/or biologics.
• Ability to interpret complex scientific issues across multiple projects and connect CMC requirements with broader global regulatory strategy.
• Knowledge of global regulatory guidance, including the relationship between CMC, clinical supplies, impurity qualification, and other development functions.

Nice to have

• Knowledge of biologics and inhalation drug-product development in the EMEA region.

Culture & Benefits

• Medical, dental, vision, and mental health coverage for eligible U.S. programs.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) matching, annual equity awards, ESPP participation, and company-paid life and disability insurance.
• Access to learning programs, LinkedIn Learning, workshops, leadership development, mentoring, and networking.
• Employee resource groups, recognition programs, volunteering, and community engagement opportunities.