Regulatory Writer, Manufacturing Science and Technology (MSAT)

Are you passionate about writing and ready to make a meaningful impact in regulatory submissions? Do you bring experience within API manufacturing processes or the regulatory field, excelling in a role with a clear purpose and direct impact on Novo Nordisk’s ability to deliver to patients? 

If you share our drive to make a difference in the production of API products, then join us today in Product Supply (PS) API MSAT Project Office department!

The position
As a Regulatory Writer, you work closely with colleagues across our newly established department and partner with teams from other parts of Novo Nordisk, including MSAT Process Support, Project Management, Quality Assurance, and Regulatory Affairs. 

You will take part in shaping the way we write our regulatory documents based on continuous learnings and feedback and be a part of a regulatory writer network covering API, drug product, and analytical procedures, striving to develop and improve the regulatory writing in Novo Nordisk.    

Your key activities include:

• Defining the regulatory storyline in collaboration with Regulatory Affairs
• Creating documentation for our portfolio of products in PS API to ensure that the required API quality is fulfilled and thereby securing the safety of our patients
• Writing and reviewing regulatory submission documents covering both new products to market and life cycle management optimizations of existing products
• Addressing questions from health authorities across the globe related to our submissions in collaboration with process supporters and subject matter experts

Qualifications
To succeed in this role, we imagine you:

• Hold a MSc. degree in Pharmacy, Chemistry, Engineering, or a similar field
• Bring a passion for writing, coupled with a keen eye for details 
• Have practical experience in the pharmaceutical industry, regulatory sector, or health authorities, with a focus on writing or reviewing regulatory documents
• Excel at organizing and prioritizing your tasks effectively
• Display full proficiency in both spoken and written English

It would be considered as a strong advantage if you have experience with the manufacturing of API’s. 

On a personal level, you have a structured and detail-oriented approach to everything you do. You take pride in delivering high-quality documents and to do so, you build and create a network to improve your knowledge and skills. While you thrive working on your own, you also effectively collaborate with various departments across the area. You are proactive and curious, bringing a can-do attitude and a mindset based on continuous improvement. 

About the Department
You will join the PS API MSAT Project Office as part of the “Project Managers & Regulatory Writers” team. The team currently consists of six dedicated regulatory writers and nine project managers. The team’s responsibility is, in collaboration with project directors and senior project managers, to ensure that the project- and regulatory activities for the PS API portfolio are handled according to project- and submission deadlines. 

We execute projects for process optimization set to improve capacity and quality and reduce cost and we support project governance that secures continuous optimization across PS API. We are deeply involved in the regulatory work associated with Life Cycle Management of the Drug Substances.

We are a skilled and inclusive team that prioritizes collaboration and personal development. You will be welcomed by colleagues who take pride in balancing ambitious goals, working hard, and maintaining a healthy and fun approach to our tasks.
  

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. 

Contact
For further information, please contact Gry Ravn Jespersen at [email protected].

Deadline
20 November 2024.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

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