Advanced Regulatory Writer

Novo; Gladsaxe Kommune; On-site; DKK 570,000 - 838,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

MSc in Life Sciences

Regulatory writing

API regulatory knowledge

Technical writing

Attention to detail

multitasking / prioritisation

Cross-functional communication

Education

MSc in Life Sciences, Pharmacy or related field

Job description

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Category: Reg Affairs & Safety Pharmacovigilance

Location: Bagsværd, Capital Region of Denmark, DK

Your impact begins here.

What you’ll bring

• An MSc in Life Sciences, Pharmacy or a related field.
• 2+ years of experience in the pharmaceutical or biotechnology industry, for example in manufacturing support, clinical or regulatory writing, or Regulatory Affairs.
• Demonstrated knowledge of, or experience with, API regulatory documentation, product registration and compliance with regulatory requirements.
• Strong technical writing skills: you produce clear, concise and complete regulatory documents, and some API process knowledge.
• Meticulous attention to detail, so documents are accurate and complete and submissions are not delayed.
• The ability to manage several regulatory tasks at once, keep to timelines and adapt when priorities change.
• Clear communication of regulatory requirements to stakeholders, and an easy way of working across functions.

Useful, but not essential:

• Experience taking part in audits or authority inspections, or in process optimisation and regulatory improvement projects.

What you’ll do

• Prepare, update and review regulatory submission documents so they meet the requirements of regulatory agencies.
• Answer questions from health authorities.
• Work with Regulatory Affairs, the project manager and process development teams to support the approval and maintenance of drug manufacturing process registrations.
• Advise on manufacturing changes to make sure they comply with regulations.
• Represent regulatory writing in project teams throughout the product lifecycle: give input to the regulatory storyline and to project plans, including timelines for preparing and approving submission documents.
• Share learnings, changes and authority signals with the department, and contribute ideas for regulatory strategies that speed up approval of product and manufacturing process changes.

Who you’ll work with

You will join the API MSAT Project Office , working as the regulatory writing representative in project teams. You will be able to work independently on most tasks, with guidance from more experienced colleagues when you need it.

Your closest internal partners are API MSAT, API manufacturing, CMC development (all including QA) , Regulatory Affairs, Global Contract Manufacturing (GCM) and Material MSAT, including primary packaging. Externally, you will work with contract manufacturing organisations (CMOs).

The role is based at the Bagsværd site, with the option to work from Gentofte and Kalundborg. Bringing different expertise together, and speaking up early when timelines or documents are at risk, is how this team moves quickly and gets to a clear decision.

What you can expect here

You will be trusted to own your documents and your voice will count in project teams. You will join cross-organisational networks, project, process and focus groups, and contribute to regulatory optimisation projects. That gives you the chance to broaden your regulatory expertise and build new skills across the value chain, with the support of experienced colleagues.

Salary:

For this role, the Annual Base Salary ranges from 570,200 to 838,100 DKK (DK), corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.