Advanced Regulatory Writer

Cari; København; Hybrid; DKK 570,000 - 838,000; Full time

Job summary

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

Based at the Bagsværd site with options to work from Gentofte and Kalundborg, you will ensure submissions are accurate, timely and compliant, answer health authority questions, and support approvals and changes to manufacturing

Qualifications

• MSc in Life Sciences, Pharmacy or a related field.
• 2+ years of experience in the pharmaceutical/biotech industry (manufacturing support, clinical or regulatory writing, or Regulatory Affairs).
• Knowledge of API regulatory documentation, product registration and regulatory compliance.
• Strong technical writing: clear, concise regulatory documents with API process knowledge.
• Meticulous attention to detail to ensure accuracy and timeliness of submissions.
• Ability to manage multiple regulatory tasks, meet timelines and adapt to changes in priorities.
• Clear communication of regulatory requirements 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 with Regulatory Affairs and project teams.
• Advise on manufacturing changes to ensure regulatory compliance.
• Represent regulatory writing in project teams across the product lifecycle and contribute to timelines.
• Share learnings and regulatory signals to speed up approvals.

Skills

Regulatory writing

Attention to detail

Cross-functional collaboration

Project management

Regulatory submissions

Education

MSc in Life Sciences/ Pharmacy or related field

Job description

Your impact begins here

As Advanced Regulatory Writer, you will help get Novo’s manufacturing processes approved and keep them approved. You will write and manage the product registration documentation that regulators rely on, and help shape the regulatory storyline with project teams across the product lifecycle. Your clear, accurate submissions keep products moving through approval, so treatments can reach the people who need them without avoidable delay.

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

You will be the link between regulatory requirements and the people who make our products. Your work helps approvals and changes move forward with clarity.

• 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.

Learn more about our Reward Philosophy.

Start now

Your impact begins today. If you are ready to turn precise regulatory writing into approvals that keep treatments moving, apply for the Advanced Regulatory Writer role by (insert application deadline). We review applications on an ongoing basis, so we encourage you as soon as possible.

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