Manager, CMC Regulatory Affairs, Global Rare Diseases (Biopharma)

TL;DR

Manager, CMC Regulatory Affairs (Biopharma): Managing CMC regulatory documents and submissions for a global portfolio of rare disease products with an accent on pre and post-approval experience. Focus on authoring CTD sections, managing change control requests, and negotiating with regulatory agencies to ensure global compliance.

Location: Must be based in Europe (remote work possible)

Salary: Minimum €46,800 (based on Italy)

Company

International research-focused biopharmaceutical group and certified B Corp focusing on the development and commercialization of treatments for rare and ultra-rare disorders.

What you will do

• Create and maintain CMC regulatory documents to support a broad range of global submissions to Regulatory Authorities.
• Author and review CMC sections for new marketing authorization applications, investigational applications, and variations worldwide.
• Act as the CMC representative at the core team level for the Global Rare Diseases portfolio.
• Advise multidisciplinary project teams on regulatory agency requirements and expectations regarding submission dossiers.
• Assess change control requests and collaborate with external CMOs on process optimizations, scale-up, and technology transfer.
• Represent the organization during GMP inspections by regulatory agencies.

Requirements

• Bachelor's degree in a Scientific or Technical Discipline (Advanced Degree strongly preferred).
• 5+ years of Regulatory CMC experience.
• Advanced knowledge of global CMC regulations, including ICH and US/EU requirements.
• Experience authoring technical documents (CTD M2 and M3 sections) and managing quality variations.
• Proficiency in quality management software (e.g., TrackWise) and regulatory document management systems.
• Must be based in Europe.

Culture & Benefits

• Competitive salary package with an annual performance-based bonus scheme.
• Comprehensive benefits including pension, private medical insurance, and wellbeing programs.
• Flexible working arrangements and remote work options.
• Robust relocation support and tax assistance services for foreign colleagues.
• Professional development opportunities within a dynamic, research-focused environment.