Senior Regulatory Writer — Drug Submissions (Denmark)

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

Zusammenfassung

Novo Nordisk A/S in Bagsværd, Denmark is seeking a Regulatory Writer with 2+ years in pharma to prepare and review regulatory submissions, communicate with health authorities, and support registrations throughout product lifecycles.

Join a collaborative team, coordinate with API MSAT, manufacturing, and QA to ensure regulatory compliance and timely approvals. Excellent written communication and attention to detail are essential.

Qualifikationen

• MSc in Life Sciences, Pharmacy or related field.
• 2+ years in pharma/biotech industry (manufacturing support, clinical or regulatory writing, or Regulatory Affairs).
• Knowledge of API regulatory documentation, product registration and compliance requirements.
• Strong technical writing: clear, concise regulatory documents and some API process knowledge.
• Meticulous attention to detail to ensure accuracy and timely submissions.
• Ability to manage several regulatory tasks, meet timelines and adapt to changing priorities.
• Clear communication of regulatory requirements to stakeholders across functions.

Aufgaben

• Prepare, update and review regulatory submission documents to meet agency requirements.
• Answer questions from health authorities.
• Support approval and maintenance of drug manufacturing process registrations.
• Advise on manufacturing changes to ensure regulatory compliance.
• Represent regulatory writing in project teams with timelines for submissions and approvals.
• Share learnings and contribute ideas for regulatory strategies to speed up approvals.

Kenntnisse

MSc in Life Sciences

Regulatory writing

API regulatory knowledge

Technical writing

Attention to detail

multitasking / prioritisation

Cross-functional communication

Ausbildung

MSc in Life Sciences, Pharmacy or related field

Jobbeschreibung

Novo Nordisk A/S in Bagsværd, Denmark is seeking a Regulatory Writer with 2+ years in pharma to prepare and review regulatory submissions, communicate with health authorities, and support registrations throughout product lifecycles.

Join a collaborative team, coordinate with API MSAT, manufacturing, and QA to ensure regulatory compliance and timely approvals. Excellent written communication and attention to detail are essential.