Instagram
youtube
Facebook

Regulatory Writer, Manufacturing Science And Technology (Msat)

2+ years
Not Disclosed
10 Nov. 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Writer – API

Location: Novo Nordisk, Denmark
Department: Product Supply (PS) API MSAT Project Office


Do you have a passion for writing and want to make a meaningful impact on regulatory submissions?

If you have experience within the pharmaceutical industry, regulatory affairs, or API manufacturing processes, and are eager to contribute to the global health and safety of patients, this is the opportunity for you. Join Novo Nordisk’s Product Supply (PS) API MSAT Project Office department and help shape the future of regulatory writing for API products.


The Position:

As a Regulatory Writer at Novo Nordisk, you will work closely with a cross-functional team including MSAT Process Support, Project Management, Quality Assurance, and Regulatory Affairs. In this role, you will help craft regulatory submission documents, ensuring the safety and quality of Novo Nordisk’s API products and optimizing life cycle management.

Your key responsibilities will include:

  • Collaborating with Regulatory Affairs: Defining the regulatory storyline for submissions and supporting new product launches and life cycle management.
  • Document Creation: Writing and reviewing regulatory submission documents to ensure compliance with global health authority requirements.
  • Cross-functional Collaboration: Engaging with subject matter experts and process supporters to address regulatory queries and ensure comprehensive, accurate submissions.
  • Global Engagement: Responding to questions from health authorities worldwide, ensuring that submissions meet regulatory expectations.

Qualifications:

To be successful in this role, we expect you to have:

  • A MSc degree in Pharmacy, Chemistry, Engineering, or a similar field.
  • A strong passion for writing and an eye for detail, with a structured approach to document preparation.
  • Practical experience in the pharmaceutical industry, regulatory sector, or with health authorities, ideally with a focus on regulatory writing or document review.
  • Excellent organizational skills, able to prioritize and manage tasks effectively.
  • Proficiency in English (both spoken and written) at a professional level.
  • Experience with API manufacturing would be a strong advantage.

On a personal level, you are proactive, detail-oriented, and possess a can-do attitude. You are comfortable working independently but excel in collaboration, continuously seeking opportunities for improvement in your work and the department.


About the Department:

You will join the PS API MSAT Project Office, where the team is responsible for managing regulatory activities, optimizing production processes, and ensuring the regulatory compliance of API products. The team consists of six regulatory writers and nine project managers, working together to ensure timely and high-quality regulatory submissions. In this collaborative environment, you will be supported in your professional development and encouraged to share best practices for continuous improvement.


Working at Novo Nordisk:

At Novo Nordisk, we embrace change and innovation. We are a dynamic company in a fast-moving industry, and we strive for excellence in everything we do. We value collaboration, personal development, and a healthy balance between ambitious goals and enjoying our work. Working at Novo Nordisk means making a real difference in patient care.


Contact:

For more information, please contact Gry Ravn Jespersen at GRYJ@novonordisk.com.


Deadline:

20 November 2024. Please note that you do not need to attach a cover letter to your application. However, we ask that you include a few sentences in your CV explaining why you are applying for the role. To ensure a fair recruitment process, please refrain from adding a photo to your CV.


Equal Opportunity Employer:

At Novo Nordisk, we are committed to creating an inclusive culture that values diversity and equal opportunity for all applicants. We believe that our diverse perspectives help us make a positive impact on the patients we serve and the communities we work in.