Principal Specialist, Regulatory Affairs (Pharmaceuticals)

Location: Deerfield, Illinois, United States

Salary: $104,000–$143,000 annually, with potential discretionary bonuses

Company

hirify.global develops healthcare products and solutions focused on improving healthcare delivery and saving and sustaining lives.

What you will do

• Develop global regulatory strategies and project plans for pharmaceutical product registrations and lifecycle management.
• Assess, communicate, and mitigate regulatory and compliance risks across cross-functional project teams.
• Prepare, review, compile, and submit regulatory documentation to health authorities.
• Respond to complex health authority inquiries and negotiate regulatory outcomes.
• Maintain marketing authorizations and regulatory licenses across global markets.
• Lead Regulatory Affairs activities, review labeling and SOPs, monitor regulatory developments, and coach less experienced colleagues.

Requirements

• Bachelor’s degree in a scientific discipline or an equivalent country-specific qualification.
• At least five years of Regulatory Affairs or related experience in pharmaceuticals, medical devices, CROs, or a similar regulated industry.
• Strong knowledge of global regulatory requirements, product registration processes, and pharmaceutical regulatory submissions.
• Project management skills with the ability to manage multiple priorities and deadlines.
• Strong written and verbal communication, collaboration, negotiation, and health authority interaction skills.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Culture & Benefits

• Collaborative work environment emphasizing ownership, accountability, trust, and courage.
• Medical and dental coverage beginning on the first day.
• Life, accident, disability, and business travel accident insurance.
• 401(k) retirement plan with employee contributions and company matching, plus an employee stock purchase plan.
• Paid holidays, 20–35 days of paid time off depending on tenure, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, commuting benefits, childcare benefits, and employee assistance programs.