Senior Director, Regulatory Affairs CMC (Biopharma)

Location: Fully remote; can be performed from anywhere. Occasional domestic and international travel of approximately 10% is expected for team meetings and events.

Salary: $222,000–$303,000 annual

Company

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

What you will do

• Lead regulatory CMC strategy for compounds across clinical development, marketing applications, and post-approval lifecycle activities.
• Plan, manage, and review regulatory submissions and CMC meeting documents for health authority interactions.
• Interpret FDA, EMA, ICH, WHO, EU, and Japanese regulations and translate requirements into CMC development plans.
• Assess CMC development gaps and challenges to support worldwide product approvability and lifecycle flexibility.
• Collaborate with scientists and external CROs/CMOs on drug substance, formulation, manufacturing, impurity, degradation product, and combination product issues.
• Lead cross-functional teams, provide regulatory advice, and support reasoned decisions on complex CMC matters.

Requirements

• Bachelor’s degree required.
• 10+ years of pharmaceutical development and regulatory CMC experience supporting both small- and large-molecule products in multinational companies.
• Experience serving as a Regulatory Affairs CMC product lead and managing end-to-end projects.
• Knowledge of US, EU, and Japanese drug and biologics regulations, including FDA, EU, ICH, and PMDA guidelines.
• Experience with manufacturing process development, impurity controls, regulatory agency interactions, and product development meetings.
• Strong communication, leadership, scientific literature review, problem-solving, and cross-functional collaboration skills.

Nice to have

• Advanced degree such as MS, PhD, or PharmD.

Culture & Benefits

• Fully remote work with connection to the hirify.global team and community.
• Medical, dental, vision, and mental health support, plus annual wellbeing reimbursement.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, service programs, and volunteer opportunities.