Director, Regulatory Sciences (Pharmaceutical)

TL;DR

Director, Regulatory Sciences (Pharmaceutical): Leading and overseeing projects for US Regulatory science clients with an accent on regulatory strategies and submissions. Focus on managing teams of professionals, ensuring compliance with FDA regulations, and driving the organization's strategic business objectives.

Location: Must be based in the United States (Remote or Hybrid supported)

Company

hirify.global provides customizable consulting solutions to biotech, med device, and pharmaceutical organizations to de-risk and accelerate drug and device programs.

What you will do

• Develop and implement the overall strategy for regulatory submissions, approvals, and maintenance.
• Lead and mentor a team of regulatory professionals to ensure high performance and professional development.
• Oversee the preparation, review, and timely submission of high-quality client deliverables.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Assurance, and Legal.
• Establish and maintain effective relationships with regulatory authorities, consultants, and CROs.
• Identify and mitigate risks associated with deliverables and submissions.

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 requirements, including the Hatch-Waxman Act.
• Proven track record of successful regulatory submissions and approvals.
• Bachelor's degree in a relevant scientific discipline (advanced degree preferred).
• Strong leadership, communication, and project management skills.

Culture & Benefits

• Support for remote working and flexible hybrid options for those near office locations.
• Commitment to diversity, equity, and inclusion, creating a space for authentic self-expression.
• Environment encouraging innovative, collaborative, and entrepreneurial spirits.
• Personal review of all applications by the recruitment team without reliance on AI screening tools.