Director - CMC Regulatory Solutions (Healthcare)

TL;DR

Director - CMC Regulatory Solutions (Healthcare): Leading and expanding a global CMC writing team to provide strategic regulatory solutions and consulting for pharmaceutical clients with an accent on CMC operations and quality oversight. Focus on building operational standards, managing client engagements, and shaping AI-generated CMC content.

Location: Must be based in the United States or Canada

Salary: $160k–$210k

Company

hirify.global is a technology-led healthcare solutions provider dedicated to enabling healthcare organizations to be future-ready through innovation and collaboration.

What you will do

• Lead, mentor, and expand a global team of CMC medical writers and experts, establishing operational standards and structures.
• Represent the CMC team as a senior subject matter expert in client meetings, focusing on regulatory strategy and project scoping.
• Oversee the quality, timelines, and compliance of CMC deliverables against contractual specifications.
• Act as a strategic advisor to the AI development team to improve the quality and accuracy of AI-generated CMC outputs.
• Collaborate with Regulatory Strategy, Manufacturing, and Go-to-Market teams to ensure unified delivery across projects.

Requirements

• Bachelor’s degree in Chemistry, Pharmacy, or a relevant scientific discipline (Master's degree required).
• 16-18 years of overall experience in CMC operations, writing, and regulatory expectations.
• Proven leadership experience at the Manager or Senior Manager level within pharma or biotech organizations.
• Experience presenting scientific data to internal leadership and external partners.
• Ability to operate as a consultant-level subject matter expert directly with clients.
• Must be based in the United States or Canada and authorized to work for any employer without sponsorship.

Nice to have

• Experience shaping or evaluating AI-assisted document workflows.
• Experience building new service lines or operational structures within regulatory writing.
• Comfort working in fast-paced, ambiguous, or start-up-like environments.
• Experience collaborating with international team members.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage.
• 401(k) retirement plan.
• Life and disability insurance.
• Paid vacation, paid holidays, and seven sick leave days.
• A culture that celebrates entrepreneurship, innovation, and empathy.