Manager, Regulatory Affairs (Biopharmaceutical)

Location: Onsite, in-person in Boca Raton, Florida, United States

Company

hirify.global is an end-to-end commercial biopharmaceutical company developing, manufacturing, and marketing specialty plasma-derived products for patients at risk of infectious diseases.

What you will do

• Provide regulatory guidance to company functions and maintain regular contact with senior Regulatory Affairs leadership.
• Prepare, review, present, and evaluate regulatory submissions throughout the product lifecycle, including IND, BLA, Orphan Drug, CTD, safety, licensing, and post-marketing submissions.
• Define regulatory strategies, submission requirements, milestones, timelines, and data-collection plans with internal departments, affiliates, contractors, vendors, and partners.
• Provide signatory approval for IND and BLA reports, amendments, and supplements, while escalating submission risks and delays.
• Oversee regulatory operations, submission tracking, project timelines, document archives, SOPs, and work instructions.
• Partner with Quality Assurance on regulatory risk assessments, mitigation strategies, and contingency planning.

Requirements

• Bachelor’s degree in Pharmaceutical, Biological, Chemical Science, or a related field; an advanced degree is desirable.
• At least 7 years of practical pharmaceutical regulatory experience across phases of drug development, or at least 5 years with a master’s degree.
• Detailed knowledge of the US Federal Food, Drug and Cosmetic Act, Code of Federal Regulations, FDA guidelines, and international harmonization standards.
• Knowledge of GMP, GCP, GDP, and GLP principles, as well as Regulatory Affairs department SOPs.
• Strong communication, collaboration, negotiation, problem-solving, and program management skills with the ability to manage conflicting deadlines and multiple projects.
• Strict adherence to FDA regulations, company compliance policies, data privacy requirements, compliance training, and reporting obligations is required.

Culture & Benefits

• 401(k) plan with employer match and immediate vesting.
• Medical, vision, life, dental, and pet insurance.
• Company-paid short-term and long-term disability coverage and holidays.
• Three weeks of paid time off during the first year.
• Tuition assistance after the first year.
• Free shuttle access to the Boca Tri-Rail station.