Associate Director, Regulatory Affairs (CMC)

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 developing treatments for 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 products in development and commercial applications, including lifecycle management.
• Develop CMC background documentation for consultations with the EMA, MHRA, and other regulatory authorities.
• Author and review CMC sections for IND/IMPD, NDA/MAA, and other regulatory submissions.
• Establish product-specific strategies and manage CMC change control reviews, approvals, and related submissions.
• Interpret EMA, ICH, WHO, and country-specific regulations while partnering with cross-functional teams.

Requirements

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

Nice to have

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

Culture & Benefits

• Fully remote work with flexible schedules and purposeful in-person collaboration.
• Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement.
• Paid time off, fertility and family-forming benefits, and caregiver support.
• 401(k) with company match, equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, and service opportunities.