Global Regulatory CMC Writer – Biologics

Genmab; København; Sur place; DKK 582 000 - 874 000; Plein temps

Avantages offerts par ce poste

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Résumé du poste

Genmab in Copenhagen, Denmark, is seeking a Regulatory CMC Writer to support global BLA/MAA/NDA filings, translating complex manufacturing and analytical data into clear regulatory narratives. You will join a dedicated CMC writing team and collaborate with scientists, project managers, and external partners to deliver high-quality submissions.

You will work with AI-enhanced tools, contribute to lifecycle maintenance, and ensure documents meet Genmab’s quality standards within tight timelines.

Qualifications

• Experience authoring and reviewing CMC regulatory sections with ownership of defined sections.
• Experience supporting global regulatory submissions (BLA/MAA/NDA) or pharma/biotech development.
• Understanding of CTD structure and CMC regulatory requirements across development stages.
• Knowledge of regulatory compliance, data integrity, and documentation standards (GxP).
• Excellent written English; ability to distill complex data into clear narratives.

Responsabilités

• Author and review Module 3 CTD sections: manufacturing, analytics, and formulation.
• Translate technical data into clear regulatory narratives with SMEs.
• Coordinate document prep with CMC PMs, QA, and external partners.
• Consolidate review comments and ensure timely approvals.
• Maintain trackers and support lifecycle maintenance of CMC docs.

Connaissances

CMC regulatory writing

GxP knowledge

Excellent written English

Attention to detail

AI writing tools

Stakeholder communication

Project coordination

Regulatory submissions

Formation

Master's degree in science

Advanced degree or certification preferred

Description du poste

Genmab in Copenhagen, Denmark, is seeking a Regulatory CMC Writer to support global BLA/MAA/NDA filings, translating complex manufacturing and analytical data into clear regulatory narratives. You will join a dedicated CMC writing team and collaborate with scientists, project managers, and external partners to deliver high-quality submissions.

You will work with AI-enhanced tools, contribute to lifecycle maintenance, and ensure documents meet Genmab’s quality standards within tight timelines.