Senior Manager, CMC Regulatory Affairs (Biopharmaceuticals)

TL;DR

Senior Manager, CMC Regulatory Affairs (Biopharmaceuticals): Managing CMC regulatory documents and submissions for a global portfolio of rare disease treatments with an accent on biologics and biopharmaceuticals. Focus on authoring CTD sections, negotiating with regulatory agencies, and ensuring global compliance with ICH and US/EU requirements.

Location: Must be based anywhere in Europe (remote work options available)

Company

An international research-focused biopharmaceutical group and certified B Corp dedicated to developing innovative treatments for rare and ultra-rare disorders.

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 authorizations and variations worldwide.
• Advise multidisciplinary project teams on regulatory agency requirements for submission dossiers.
• Manage change control requests and collaborate with external CMOs on process optimizations and technology transfer.
• Negotiate strategies and actions with regulatory agencies regarding CMC submission dossiers.
• Represent the organization during GMP inspections and maintain up-to-date knowledge of evolving CMC regulations.

Requirements

• Bachelor’s degree in a Scientific or Technical Discipline (Advanced Degree strongly preferred).
• 7+ years of Regulatory CMC experience.
• 3+ years of experience in Biologics/Biopharmaceuticals (mandatory).
• Advanced knowledge of global CMC regulations, including ICH and US/EU requirements.
• Experience authoring technical documents (CTD M2/M3) and managing quality variations.
• Proficiency in TrackWise and regulatory document information management systems.

Nice to have

• Strong attention to detail and ability to prioritize complex tasks.
• Excellent oral, written, and interpersonal communication skills.
• Ability to work independently and thrive in a fast-paced environment.

Culture & Benefits

• Comprehensive healthcare programs and work-life balance initiatives.
• Flexible working arrangements and remote work options.
• Competitive salary package including performance bonuses.
• Robust relocation support and tax assistance services for foreign colleagues.
• Dynamic, friendly environment with dedicated resources for professional training and development.