Regulatory Affairs Specialist

6 days ago

Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

Select how often (in days) to receive an alert: Create Alert

Category: Reg Affairs & Safety Pharmacovigilance

Location:

Søborg, Capital Region of Denmark, DK

Are you driven by the challenge of ensuring effective planning for regulatory submissions worldwide? Do you seek an exciting opportunity to shape global regulatory LCM strategies and contribute to reaching more patients? Are you passionate about long-term regulatory planning and driving improvements within a dynamic team?

Novo Nordisk is seeking a highly skilled and experienced Strategic RA Planning Specialist to join our Regulatory Affairs (RA) CMC & Device team in Søborg, Denmark. In this pivotal role, you will be instrumental in driving governance for the prioritization of regulatory plans for LCM projects, ensuring strategic long-term planning, partnering with stakeholders in Product Supply and affiliates to ensure alignment, and driving improvement initiatives. This is your opportunity to make a significant impact in a global, patient-centered organization.

The Position
We are looking for a highly skilled and experienced Strategic RA Planning Specialist to join our RA Processes and Planning team. As a partner to Novo Nordisk affiliates worldwide, RA areas, and product supply, you will be responsible for submission planning of global rollouts of life cycle management variations – enabling the RA headquarter function to support affiliates with realistic, transparent plans. This role is crucial for driving governance setup for the prioritization of LCM activities, ensuring strategic long-term planning, and managing improvement initiatives within the RA Planning area. The successful candidate will demonstrate subject matter expertise and act as a mentor to colleagues.

Your main responsibilities include:

  1. Driving governance setup for prioritizing regulatory activities across RA CMC & Device, affiliates, and Product Supply.
  2. Ensuring strategic long-term planning for life cycle management variations to optimize supply.
  3. Leading RA Planning improvement initiatives.
  4. Maintaining a comprehensive overview of all planning activities.
  5. Acting as a project manager to create simulations and scenarios for long-term planning of LCM projects in RA.
  6. Ensuring information flow and alignment across projects and therapeutic areas.

Qualifications

We require the candidate to have a minimum of a Master's degree in life sciences, or a PhD. For this role, we are seeking candidates with:

  1. More than 5 years of experience in a relevant field – e.g. regulatory planning, a strong understanding of global regulatory requirements and/or experience with supply planning or similar.
  2. Expertise in handling RA variations in life cycle management of pharmaceutical products.
  3. Good communication skills, with the ability to present complex data to senior stakeholders.
  4. Fluency in English (both spoken and written).

On a personal level, we highly value candidates who are committed, accountable, and adaptable. The ideal candidate is a strategic thinker capable of navigating complexity and ambiguity. Furthermore, strong interpersonal skills with an inclusive mindset are key to success in this role.

About the Department
You will be anchored in RA Planning and Processes, a department in the area Submission Excellence in RA CMC & Device. RA Planning & Processes currently comprise of 9 colleagues. The primary responsibility of the team is to manage planning of all regulatory LCM submissions across the world, and to ensure efficient processes across areas in RA CMC & Device. Our main stakeholders are Product Supply, Supply Chain, Regulatory functions in the global affiliates and headquarter, primarily within RA CMC & Device.

Working at Novo Nordisk
At Novo Nordisk, we drive change and innovation, striving for excellence while embracing experimentation. Our mission is to move the needle on patient care through cutting-edge research, development, manufacturing, and marketing.

Deadline
26 January 2025. We will review applications on an ongoing basis, so we encourage you to apply as soon as possible.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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