Category: Reg Affairs & Safety Pharmacovigilance
Location: Gatwick, South East, GB
For over 100 years we have been driving change to defeat diabetes, but we know that what got us here today is not necessarily what will make us successful in the future. We are now transforming our business and taking our expertise into new territories including obesity and rare blood and endocrine diseases.
The position
Would you like to play a key role in the development and delivery of new therapies to patients? Do you have experience working with biologics and supporting the introduction of new treatments to the market? If so, we are recruiting for an opportunity that aligns with your expertise.
As a Regulatory Affairs Lead at Novo Nordisk, you will:
* Manage, plan, and execute regulatory initiatives within the UK Regulatory, Safety, and Medical Information (RSM) team.
* Offer technical and strategic support to the Director of RSM and the UK Regulatory Affairs team.
* Prepare and deliver timely and competitive submissions to the MHRA, aligning with national and EMA regulatory requirements.
* Collaborate across UK business and with Global and Regional teams to align regulatory strategies with business needs.
* Provide regulatory expertise to team members by ensuring prioritisation and efficiencies for Life Cycle management of all UK products.
You will also drive pipeline management, innovative initiatives, GxP activities, and strategic regulatory projects to support and elevate organizational success.
This is a hybrid role, requiring two days per week in our office in Gatwick.
Qualifications
To be successful in this role we imagine that you possess:
* A science degree (or equivalent) with a proven track record in regulatory projects, extensive knowledge of UK and EU regulatory legislation, and solid pharmaceutical industry experience.
* Experience in biologics and prescription medicines, including successfully bringing innovative therapies to market, is essential.
* Strong communication, presentation, decision-making, and stakeholder management abilities, along with the capacity to prioritize tasks and lead complex projects.
* Organizational skills, while being proactive, and adaptable, with the ability to work effectively both independently and collaboratively within a team.
* Experience in team leadership or demonstrated strong leadership skills is an advantage.
* Fluent in written and spoken English with a solid understanding of regulatory intelligence interpretation.
About the department
In this role, you will report to the Director of Regulatory, Safety, and Medical Information and collaborate closely with the UK Regulatory team, consisting of seven dedicated members who work seamlessly together.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them.
What We Offer
* Bonus: We do our best work to succeed together. When goals are reached, you’ll be rewarded through our bonus scheme.
* Your workplace: Our offices will be your primary workplace but with flexibility to work 2-3 days at home during your working week.
* Pension: a market leading pension scheme with generous employer contributions.
* Wellness: We want you to be your best self, so you’ll have access to an award winning Wellness programme, including Private Medical Insurance.
* Insurances: All colleagues are covered by our private medical, life and disability insurance which provides protection and peace of mind.
* Inclusive culture: our culture is one of care, support and respect for our people.
Application support
We are an equal opportunities employer and we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. If you're a person with a disability, if you're neurodivergent, and need any adjustments to be made during the application and selection process, please send an email to Gitte, gifj@novonordisk.com.
Contact
We can’t accept directly sent CV, please submit your application via the “Apply” button.
Deadline
1st of February 2025
#J-18808-Ljbffr