Senior Manager, CMC Global Regulatory Affairs

Location: Remote

Salary: $150,034–$224,250, plus incentive opportunity. The stated range applies to individuals hired in the United States.

Company

hirify.global develops and commercializes pharmaceutical products, including small-molecule and biological therapies.

What you will do

• Develop and implement global CMC regulatory strategies for late-stage development, marketing applications, and post-approval lifecycle activities.
• Plan, prepare, and review CMC sections for submissions including IND, IMPD, NDA, MAA, ASMF, CEP, and post-approval variations.
• Lead responses to Health Authority questions and deficiency letters and represent CMC Regulatory Affairs in regulatory meetings and negotiations.
• Serve as the CMC regulatory lead on global cross-functional teams spanning pharmaceutical development, quality, manufacturing, and regulatory strategy.
• Assess regulatory strategies for technical changes, process improvements, new product introductions, line extensions, and global registration harmonization.
• Collaborate with internal functions, affiliates, external partners, contract manufacturers, packagers, and suppliers.

Requirements

• BS, MS, or PhD in Chemistry, Pharmacy, or a related scientific discipline.
• 7+ years of experience in CMC Regulatory Affairs, with significant small-molecule experience required.
• Proven experience with late-stage investigational filings, NDA/MAA submissions, global submissions, and post-marketing lifecycle management as a CMC regulatory lead.
• Comprehensive knowledge of drug development, pharmaceutical technology, manufacturing processes, analytical and quality control, GMP, and global CMC regulatory requirements.
• Experience preparing CMC quality sections for EMA, UK, CH, US, and Canadian submissions.
• Strong analytical, problem-solving, organizational, leadership, communication, negotiation, and cross-cultural collaboration skills.

Nice to have

• Experience with biologic, peptide, or oligonucleotide products.
• Experience handling controlled-substance applications.
• Experience as a CMC reviewer or assessor with EMA, EU, UK, or FDA regulatory agencies.

Culture & Benefits

• Remote work environment with collaboration across local and global functional units.
• Medical, dental, vision, prescription drug, life, disability, and other insurance coverage.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
• Opportunities to improve departmental procedures, processes, and operational efficiency.