Regulatory Content Specialist, Pharmaceutical Operations and Innovation

3 weeks ago


Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

Are you passionate about crafting high-quality regulatory content that drives meaningful impact in pharmaceutical operations? Do you bring experience in API manufacturing processes or the regulatory field, with a keen eye for detail and a knack for collaboration?

As a Regulatory Content Specialist, you will play a crucial role in shaping the way we write our regulatory documents, working closely with colleagues across our department and partner teams from other parts of Novo Nordisk. You will be part of a regulatory writer network covering API, drug product, and analytical procedures, striving to develop and improve regulatory writing in Novo Nordisk.

Your key responsibilities will include:

  1. Defining the regulatory storyline in collaboration with Regulatory Affairs, ensuring a clear and compelling narrative that drives business success.
  2. Creating documentation for our portfolio of products in PS API, ensuring that the required API quality is fulfilled and securing the safety of our patients.
  3. Writing and reviewing regulatory submission documents, covering both new products to market and life cycle management optimizations of existing products.
  4. Addressing questions from health authorities across the globe related to our submissions, collaborating with process supporters and subject matter experts.

To succeed in this role, we imagine you:

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

An estimated salary for this role is $90,000 - $110,000 per year, depending on location and experience.

At Novo Nordisk, we drive change by embracing the spirit of experimentation, striving for excellence without fixating on perfection. We're a dynamic company in a 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 never shy away from opportunities to develop, we seize them.

Join our team of skilled professionals who prioritize collaboration and personal development. We're a company that values a healthy work-life balance, and we're committed to making a meaningful difference in the lives of patients.

If you're a motivated and detail-oriented individual with a passion for regulatory content, we encourage you to apply for this exciting opportunity.

Note: The salary mentioned above is an estimate and may vary based on the location and experience of the candidate. The actual salary will be discussed during the recruitment process.

The estimated annual salary for this position is $100,000, based on industry standards and the requirements of the role.



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