(Senior) Regulatory Professionals for CagriSema Obesity & Amylin

Would you like to drive regulatory strategies within weight management for initial submissions to authorities on a global scale? And are you able to cut through complexity and work across multiple functions in a very dynamic environment? If yes, join us as a Regulatory Professional or Senior Regulatory Professional in Global Regulatory Affairs and be part of a team committed to making a difference in the lives of patients worldwide. Apply now for a life-changing career opportunity! The position
As a Regulatory Professional or Senior Regulatory Professional, you will play a crucial role in the development and execution of regulatory strategies. This will entail close collaboration with the Global Regulatory Lead - working together to prepare the global submission of a new product within weight management or finalise the strategy for a new formulation. You will drive and coordinate several regulatory activities with challenging and often overlapping timelines. In addition, you willbe a member of various cross functional project teams including study groups, and as such, interact with a variety of stakeholders from different departments in [xxxxx]. Your main responsibilities will be focused on:

Contributing with regulatory expertise to global strategies and tactics

Participating in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports

Developing local strategies in collaboration with stakeholders in affiliates to ensure alignment between local and global regulatory strategies

Providing regulatory input, be proactive, challenge the discussions and contribute to project team decisions

Interacting with medical and non-clinical specialists, statisticians, and medical writers

You will report to the Team Leader of RA CagriSema Obesity & Amylin and actively participate in department-related activities, including improvement projects across Regulatory Affairs. Qualifications
To be a competitive candidate, you should have:

Master's degree within Life Science, Health Science, or any related field

Demonstrated experience in Regulatory Affairs or other relevant area in drug development within the pharma industry and/or health authorities

Experience with health authorities interactions is a strong advantage

Strong IT/digital skills

Professional proficiency in English

Personally, you like to experiment and see opportunities rather than limitations in challenging situations and you are a team player who assists your colleagues and works for joint objectives, shows an inclusive mindset, and respects the diversity in others. You should be well-organised, possess robust problem-solving capabilities, and maintain a strategic focus. A positive, can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humour under pressure. Effective communication skills that enable cooperation at all organisational levels are highly valued.
About the department
RA CagriSema Obesity & Amylin currently consists of 13 dedicated and highly engaged employees. Our department is responsible for the development of global regulatory strategies to advance the project from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications. We work as an integrated part of the global development organisation and play a key role in the cross-functional teams. We are responsible for the development, implementation and execution of global regulatory strategies and regulatory operational activities in alignment with the global project development plan. We drive label development, health authority interactions and regulatory submissions, hereunder initial marketing authorisation applications, paediatric plans, and clinical trial applications. We have a close collaboration with our affiliates and global stakeholders. 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Christina Winther Poulsen, Regulatory Affairs Team Leader at [xxxxx] Deadline
2 June 2024.
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.