Associate Manager, Regulatory Affairs Strategy - Oncology

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

Salary: $109,900–$179,300 annually

Company

hirify.global is a science-driven biotechnology company developing medicines for people with serious diseases.

What you will do

• Coordinate the preparation, submission, management, and maintenance of global regulatory submissions for oncology clinical and nonclinical development programs.
• Support INDs, CTAs, amendments, information requests, orphan drug applications, annual reports, and investigator brochures.
• Assist with agency meeting coordination and preparation of briefing documents.
• Manage regulatory agency queries and commitments, coordinating written responses with subject matter experts.
• Represent study-level regulatory activities and participate in cross-functional development projects and meetings.
• Research regulatory requirements and support regulatory strategy while communicating changes in guidance and regulations.

Requirements

• MD, PhD, or PharmD degree with relevant internship, fellowship, postdoctoral, or industry experience.
• Knowledge of US FDA and international pharmaceutical guidance, regulations, drug development processes, and industry practices.
• Strong attention to detail and the ability to organize and prioritize projects according to corporate goals.
• Ability to collaborate closely with regulatory colleagues and the broader development organization.
• Proficient written, oral, and interpersonal communication in English.

Nice to have

• Experience in oncology.
• Experience working with CROs to manage ex-US and ex-EU CTAs through clinical trial activation.

Culture & Benefits

• Science-driven work focused on developing life-changing medicines.
• Inclusive workplace and equal-opportunity employment environment.
• Competitive total rewards package that may include bonuses, equity awards, retirement benefits, health insurance, paid time off, and family support benefits.
• Onsite collaboration is emphasized for this role.