Manager, Regulatory Affairs Strategy - Oncology

Location: Tarrytown, New York, or Warren, New Jersey, United States; 4 days per week onsite

Salary: $128,600–$210,000 annually

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for serious diseases, including cancer and other complex conditions.

What you will do

• Coordinate the preparation, submission, management, and maintenance of global regulatory submissions for clinical and nonclinical product development.
• Prepare and support INDs, CTAs, amendments, information requests, orphan drug applications, annual reports, and investigator brochures.
• Coordinate agency meetings and prepare related briefing documents.
• Track regulatory-agency queries and commitments, coordinating written responses with subject matter experts.
• Represent study-level regulatory activities and participate in cross-functional product-development projects and meetings.

Requirements

• MD, PhD, or PharmD degree required.
• At least 2 years of regulatory experience required.
• Experience working on filings, developing regulatory documents, and engaging with external partners and regulatory authorities.
• Understanding of US FDA and international pharmaceutical guidance, regulations, drug development processes, and industry practices.
• Strong attention to detail, project coordination, prioritization, and written and verbal interpersonal skills.
• Onsite presence 4 days per week in Tarrytown, NY, or Warren, NJ.

Culture & Benefits

• Science-driven environment focused on developing medicines for serious diseases.
• Inclusive workplace and equal-opportunity employment practices.
• Competitive total rewards package that may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodations are available during the recruitment process where required.