Senior Regulatory Writer — Drug Submissions & Strategy

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

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