Manager, Regulatory Affairs Strategy - Oncology (Biotech)

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

Salary: $128,600–$210,000 annually

Company

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

What you will do

• Coordinate the preparation, submission, management, and maintenance of global regulatory filings 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.
• Lead and track regulatory agency queries and commitments, working with subject matter experts on written responses.
• Represent study-level regulatory activities and contribute to cross-functional product development projects and meetings.

Requirements

• MD, PhD, or PharmD degree and at least 2 years of regulatory experience.
• 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.
• High attention to detail and the ability to coordinate and prioritize projects according to company goals.
• Strong written and verbal interpersonal communication skills.

Nice to have

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

Culture & Benefits

• Inclusive workplace culture and equal employment opportunity.
• Comprehensive rewards may include annual 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.

Hiring process

• Background checks may verify identity, right to work, and educational qualifications where permitted by local law.