Director, Regulatory Sciences

TL;DR

Director, Regulatory Sciences (Pharmaceuticals): Leading and overseeing regulatory strategy and submission projects for US clients with an accent on FDA compliance and cross-functional collaboration. Focus on managing high-performance teams, driving regulatory approvals, and mitigating risks across the product lifecycle.

Location: Must be based in the United States. Hybrid work is encouraged for those within commuting distance of an office.

Company

hirify.global provides expert consulting and operational support to biotech, med device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Develop and implement comprehensive regulatory strategies for submissions, approvals, and maintenance.
• Lead, mentor, and develop a team of regulatory professionals to ensure high performance.
• Oversee the preparation and review of high-quality client deliverables and manage interactions with regulatory authorities.
• Collaborate with cross-functional teams including R&D, Manufacturing, Quality, and Legal.
• Provide robust quality oversight to ensure adherence to regulatory requirements and industry best practices.
• Identify and mitigate risks associated with regulatory submissions and project timelines.

Requirements

• Must be based in the United States.
• Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of FDA regulations, guidelines, and the Hatch-Waxman Act.
• Proven track record of successful regulatory submissions and approvals.
• Strong leadership experience managing high-performance teams.
• Bachelor's degree in a relevant scientific discipline (advanced degree preferred).

Culture & Benefits

• Commitment to diversity, equity, and inclusion in the workplace.
• Supportive environment that encourages innovation, collaboration, and entrepreneurial spirit.
• Equal Opportunity Employer with a focus on employee empowerment.
• Hybrid work model supported for those near office locations.