Senior Manager - CMC Regulatory Solutions (AI)

TL;DR

Senior Manager - CMC Regulatory Solutions (AI): Leading and expanding a global CMC writing team within a regulatory services business with an accent on strategic CMC consulting and operational excellence. Focus on shaping best practices for AI-generated CMC content, managing client engagements, and ensuring high-quality regulatory deliverables.

Location: Must be based in the United States or Canada. This position is either fully remote or hybrid remote.

Salary: $150,000–$185,000

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.
• Serve as a senior subject matter expert in client meetings, regulatory strategy discussions, and project scoping.
• Oversee quality, timelines, and compliance for CMC deliverables.
• Advise on and drive the development of AI-generated CMC outputs by collaborating with AI platform teams.
• Contribute to the development of CMC operating models, processes, and procedural documentation.
• Collaborate cross-functionally with Regulatory Strategy, Manufacturing, and Go-to-Market teams.

Requirements

• Must be based in the United States or Canada and authorized to work for any employer.
• Bachelor’s degree in Chemistry, Pharmacy, or a relevant scientific discipline plus a Master's degree.
• 16-18 years of experience in CMC operations, writing, and regulatory expectations.
• Proven leadership experience at the Manager or Senior Manager level in pharma or biotech.
• Demonstrated experience presenting scientific data to leadership and external partners.
• Strong business acumen and experience managing cross-functional stakeholders.

Nice to have

• Experience shaping or evaluating AI-assisted document workflows.
• Knowledge of building new service lines or operational structures within regulatory writing.
• Ability to work in fast-paced, ambiguous, or start-up-like environments.

Culture & Benefits

• Comprehensive benefits package including medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) retirement plan.
• Paid time off including vacation, sick leave, and paid holidays.
• Commitment to inclusion, diversity, and pay equity.