Senior Manager, CMC Regulatory Affairs (Rare Diseases)

TL;DR

Senior Manager, CMC Regulatory Affairs (Rare Diseases): Managing CMC regulatory documents and submissions for a global portfolio of commercial products for rare disorders with an accent on global regulatory compliance and lifecycle management. Focus on authoring CTD sections, negotiating with regulatory agencies, and ensuring alignment with ICH and US/EU requirements.

Location: Hybrid role based in Cary, NC, US

Salary: $121,000 – $182,000

Company

An international research-focused biopharmaceutical group with 90 years of experience, specializing in innovative treatments for rare and ultra-rare disorders.

What you will do

• Maintain and create CMC regulatory documents to support a wide range of global submissions to Regulatory Authorities.
• Author and review CMC sections (CTD M2 and M3) for new marketing authorization applications and variations worldwide.
• Advise multidisciplinary project teams on regulatory agency requirements and expectations regarding CMC sections.
• Review and assess change control requests pertaining to the CMC aspects of the product portfolio.
• Negotiate strategies and actions with regulatory agencies in alignment with global and regional functions.
• Represent the company during GMP inspections by regulatory agencies.

Requirements

• 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 regulatory requirements.
• Experience 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.

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 for eligible candidates.
• Performance-based bonuses.
• Dynamic, friendly environment with continuous access to resources and training.