Manager, CMC Regulatory Affairs (Pharma)

TL;DR

Manager, CMC Regulatory Affairs (Pharma): Managing CMC regulatory documents and submissions for a global rare diseases portfolio with an accent on global regulatory strategy and compliance. Focus on authoring CTD sections, negotiating with regulatory agencies, and overseeing the product life cycle.

Location: Hybrid role based in Cary, NC, USA

Salary: $121,000 – $182,000

Company

hirify.global is an international research-focused biopharmaceutical group operating in 31 countries, focused on driving sustainable innovation in healthcare.

What you will do

• Create and maintain CMC regulatory documents for a broad range of global submissions.
• Author and review CMC sections (CTD M2 and M3) for marketing authorization applications and variations worldwide.
• Advise multidisciplinary project teams on regulatory agency requirements and expectations.
• Review and assess change control requests pertaining to CMC aspects of the product portfolio.
• Collaborate with external CMOs on process optimizations, scale-up, and technology transfer activities.
• Negotiate regulatory strategies and actions with agencies regarding submission dossiers.

Requirements

• Minimum of a bachelor’s degree in a Scientific or Technical Discipline.
• 5+ years of Regulatory CMC experience.
• Advanced knowledge of global CMC regulations, including ICH and US/EU requirements.
• Experience in authoring technical documents and managing quality variations.
• Proficiency in quality management software (e.g., TrackWise).
• Must be based in or able to work from the Cary, NC office (Hybrid).

Nice to have

• Advanced Degree in a Scientific or Technical Discipline.

Culture & Benefits

• Comprehensive healthcare programs and competitive salary package.
• Work-life balance initiatives and flexible working arrangements.
• Robust relocation support.
• Performance bonuses and access to professional training resources.
• Support for foreign colleagues via tax assistance services.