Associate Director, Regulatory Affairs (CMC) (Biopharmaceuticals)

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

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Plan and coordinate regulatory submissions for products in development, commercial applications, and lifecycle management in the EMEA region.
• Coordinate with cross-functional teams to achieve short- and long-term regulatory objectives.
• Lead 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.
• Develop product-specific CMC strategies for early development, registration, and lifecycle management.
• Review and approve CMC change controls and interpret applicable regulatory requirements.

Requirements

• Bachelor’s degree and 5–7 years of pharmaceutical development and regulatory CMC experience in the biotechnology or pharmaceutical industry.
• Experience working in a GMP environment with a strong understanding of industry regulations and best practices.
• Strong knowledge of EU, ICH, WHO, and other country-specific regulations and guidance for small molecules and/or biologics.
• Ability to interpret complex scientific issues across multiple projects and connect CMC requirements with broader global regulatory strategy.
• Fully remote work from anywhere is supported; occasional travel for team meetings or events is expected.

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, and vision coverage, mental health support, and wellbeing reimbursement.
• Paid time off, fertility and family-forming benefits, and caregiver support.
• 401(k) plan with company match, equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, networking opportunities, employee resource groups, and service programs.