Director, Regulatory Affairs, Pharmaceuticals

Location: Hybrid in Horsham, Pennsylvania, USA

Company

hirify.global is a global full-service contract research organization providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Lead the regulatory affairs function across North America and provide strategic and tactical direction.
• Advise biopharmaceutical clients and serve as a subject matter expert on regulatory projects.
• Develop and implement global regulatory strategies in collaboration with international regulatory colleagues.
• Manage, oversee, and prepare regulatory documents and submissions, including INDs, CTAs, BLAs, MAAs, and NDAs.
• Monitor regulatory developments, assess business impact, and communicate changes to teams and senior leadership.
• Hire, develop, mentor, and support regulatory personnel and department growth.

Requirements

• Bachelor’s degree in a scientific field; an advanced degree such as PharmD, PhD, or MS is preferred.
• At least eight years of regulatory affairs experience with biopharmaceutical products, including small and large molecules, combination products, or vaccines.
• Experience developing regulatory strategies for INDs, CTAs, NDAs, MAAs, or BLAs with a record of successful approvals.
• Direct experience working with the FDA and other health authorities; CBER and global biologics experience are highly desirable.
• Strong knowledge of regulatory affairs across development, CMC, labeling, promotion, commercialization, and operations.
• Excellent communication, strategic thinking, collaboration, and team leadership skills, with comfort working in an ambiguous, fast-paced environment.

Nice to have

• Phase I through Phase III product experience.
• Experience with CBER and global biologics.
• Experience supporting digital technology solutions for regulatory affairs and operations.

Culture & Benefits

• Permanent employment with a hybrid work arrangement.
• Collaborative, quality-focused one-team culture.
• Professional development supported through continuous training and mentoring.
• Work-life balance and an inclusive, equal-opportunity environment.
• Opportunity to work with pharmaceutical, biotechnology, medical device, and consumer health clients across global markets.

Hiring process

• Application acknowledgement is sent after CV submission.
• Qualified candidates are invited to a phone interview as the first step.