Senior Regulatory Writer: Drug Submissions & Compliance

Novo Nordisk; Gladsaxe Kommune; Vor Ort; DKK 570.000 - 838.000; Vollzeit

Zusammenfassung

Novo Nordisk in Denmark is seeking an Advanced Regulatory Writer to help get manufacturing processes approved and kept approved. You will write and manage product registration documentation relied on by regulators, and shape the regulatory storyline with project teams across the product lifecycle.

You will act as the link between regulatory requirements and the teams that make our products, ensuring submissions are clear, accurate and timely.

Qualifikationen

• MSc in Life Sciences, Pharmacy or related field.
• 2+ years in pharma/biotech incl regulatory writing or regulatory affairs.
• Knowledge of API regulatory docs, product registrations and regulatory compliance.
• Strong technical writing: clear, concise regulatory documents.

Aufgaben

• Prepare, update and review regulatory submission documents to meet agency requirements.
• Answer questions from health authorities.
• Collaborate with Regulatory Affairs, project managers and process development teams to support approvals and maintenance of drug manufacturing registrations.
• Advise on manufacturing changes to ensure regulatory compliance.
• Represent regulatory writing in project teams across the product lifecycle and contribute to regulatory strategies.
• Share learnings and authority signals with the department to speed up approvals.

Kenntnisse

Regulatory writing

API regulatory docs

Technical writing

Attention to detail

Multitasking

Cross-functional collaboration

Stakeholder communication

Ausbildung

MSc in Life Sciences, Pharmacy or related field

Jobbeschreibung

Novo Nordisk in Denmark is seeking an Advanced Regulatory Writer to help get manufacturing processes approved and kept approved. You will write and manage product registration documentation relied on by regulators, and shape the regulatory storyline with project teams across the product lifecycle.

You will act as the link between regulatory requirements and the teams that make our products, ensuring submissions are clear, accurate and timely.