Senior RA Professional, Semaglutide Outcomes Trial

Are you ready to explore the thrilling realm of Regulatory Affairs at [xxxxx]? Do you have a robust scientific background and a passion for advancing treatments in cardiometabolic and renal disease?
If yes, don't miss this incredible chance! Apply today and become part of a vibrant, diverse team dedicated to securing global approvals for our groundbreaking medicines. The position
As a Senior RA Professional, you will be working in close collaboration with our experienced RA specialists , driving a variety of regulatory tasks with challenging and often overlapping timelines for our Semaglutide Cardiovascular Outcomes Trial (CVOT). Moreover, you will interact with multiple stakeholders - such as project managers, medical and non-clinical specialists, statisticians, and medical writers – across different markets on a global scale

Your main responsibilities will be focused on:

Creating and maintaining Regulatory Affairs Submission Plan

Planning and conducting regulatory interactions with health authorities, including preparation of meeting requests and meeting packages

Being responsible for the development of the national labelling for new products in development

Participating in strategic project discussions, actively contributing to regulatory strategies and challenging discussions

Contributing to initiatives aimed at optimising regulatory processes across the organization

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site work in Søborg, Denmark where our team is based.
Qualifications
To be a competitive candidate, you should have:

A master’s degree and/or a Ph.D. within Life Science, Health Science, or a related field

Demonstrated experience working within Regulatory Affairs in the pharmaceutical industry

Solid practice with handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical areas

Experience interacting directly with regulatory authorities on an international scale would be an advantage

Strong project management skills

Fluent written and spoken English

As a person, you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. Your adept communication skills span across all levels of an organization.
About the department
RA SEMA is responsible for defining and driving regulatory strategies for our semaglutide & cagrisema projects in all phases of development. We are a team of dedicated and highly engaged employees who work as an integrated part of global development and research projects and play a key role in cross-functional teams. We are responsible for the semaglutide and cagrisema regulatory strategy and provide regulatory expertise and tactics to product development plans. We drive label development, health authority interactions, and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams.
Working at [xxxxx]
At [xxxxx], 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 the Hiring Manager - Helene Nordahl at +[xxxxx]. Deadline
23 June 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.

By submitting your application for this position, you acknowledge and agree that your CV and application materials may be accessible and viewed by relevant managers within our organization (Global Regulatory Affairs) for the purpose of evaluating your candidacy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] 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.