Regulatory Affairs Lead
Regulatory Affairs Lead
Posted on :
27-01-2025
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1 Vacancy
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Job Description
Job Title: Regulatory Affairs Lead
Job Location: London Gatwick Airport (LGW) Horley Gatwick RH6 0NP UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level:
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.
Our story is one of incredible growth and success which has culminated in receiving many prestigious awards such as Best Places to Work and Vitality – Britain’s Healthiest Workplace.
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:
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:
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.
Our team is proud to have achieved exceptional Employee survey results including a perfect 100 score in areas such as teamwork valuing diverse perspectives and mutual respect from their manager. Additionally we scored 100 in the Purpose category reflecting our shared commitment to meaningful and impactful work.
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. Working at Novo Nordisk is working toward something bigger than ourselves and it’s a collective effort. Together we go further. Together we’re life changing.
What We Offer
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 . Please include your name the role you are interested in and the type of adjustment your need.
Contact
We can’t accept directly sent CV please submit your application via the “Apply” button.
Deadline
1st of February 2025
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.
Our story is one of incredible growth and success which has culminated in receiving many prestigious awards such as Best Places to Work and Vitality – Britain’s Healthiest Workplace.
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
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 decisionmaking 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.
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.
Our team is proud to have achieved exceptional Employee survey results including a perfect 100 score in areas such as teamwork valuing diverse perspectives and mutual respect from their manager. Additionally we scored 100 in the Purpose category reflecting our shared commitment to meaningful and impactful work.
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. Working at Novo Nordisk is working toward something bigger than ourselves and it’s a collective effort. Together we go further. Together we’re life changing.
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 23 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. We are committed to making your workplace safe and believe that a transparent inclusive culture and leadership is the way to empower every individual to do their very best
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 . Please include your name the role you are interested in and the type of adjustment your need.
Contact
We can’t accept directly sent CV please submit your application via the “Apply” button.
Deadline
1st of February 2025
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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Employment Type
Full Time
Key Skills
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