(Senior) Regulatory Affairs Professional, RA Obesity
Søborg
Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative medicines to patients?
If so, join our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who a play pivotal role in developing innovative obesity treatments.
The position
Our Regulatory Affairs Professionals support the development of regulatory strategies and are responsible for various regulatory tasks within cross-functional project teams, such as clinical study groups and submission teams.
This role entails interactions with various stakeholders throughout the organization, and in particular a very close collaboration with the Global Regulatory Lead and other regulatory teams, as we work together to progress the development programs through End-of-Phase 2 interactions and initiation of phase 3 development.
Key responsibilities will be focused on: Contributing with regulatory expertise to global strategies and tactics Coordinating the planning and preparation of regulatory documentation such as global clinical trial applications, briefing packages, paediatric plans, and responses to health authority questions Supporting the planning and conduct of regulatory interactions with Health Authorities worldwide regarding clinical trial activities, scientific advice, regulatory submissions and approvals Collaborating effectively with cross-functional stakeholders such as project managers, medical and non-clinical specialists, statisticians, medical writers, as well as other regulatory colleagues to provide regulatory input and contributing to project decisions Being actively involved in establishing internal positions on regulatory issues, new and changing guidelines, and improvement projects across Regulatory Affairs As our teams are expanding and we are searching for several RA professionals, the level of seniority of the positions will be assessed based on relevant experience and specific competences to match project needs. 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 office-based work in Søborg, Denmark where our team is based. Qualifications
We expect an ideal candidate to have the following: Master's degree or PhD within Life Science, Health Science, or a related field A minimum of 3-4 years of relevant regulatory experience, preferably from the pharmaceutical industry or Health Authority Experience working on clinical development programs from phase 2 to phase 3 is an advantage Advanced communication skills in both written and spoken English, to enable effective cooperation at all organisational levels Strong IT/digital skills Personally, you thrive in fast-paced, collaborative environments and actively contribute to the team's success. 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. About the department
RA Obesity is a new and expanding area within Global Regulatory Affairs and will soon consist of 25 dedicated and highly engaged Managers, Global Regulatory Leads, Regulatory Specialists, and Regulatory Professionals, organised into three teams. We are currently managing multiple active projects that span a wide array of domains and functional areas.
Our department is charged with delivering and executing on global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.
We are responsible for driving label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, paediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations. Working at
At , 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 Paolo Voltolina at Deadline
9 June 2024. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application. 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 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.
If so, join our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who a play pivotal role in developing innovative obesity treatments.
The position
Our Regulatory Affairs Professionals support the development of regulatory strategies and are responsible for various regulatory tasks within cross-functional project teams, such as clinical study groups and submission teams.
This role entails interactions with various stakeholders throughout the organization, and in particular a very close collaboration with the Global Regulatory Lead and other regulatory teams, as we work together to progress the development programs through End-of-Phase 2 interactions and initiation of phase 3 development.
Key responsibilities will be focused on:
We expect an ideal candidate to have the following:
RA Obesity is a new and expanding area within Global Regulatory Affairs and will soon consist of 25 dedicated and highly engaged Managers, Global Regulatory Leads, Regulatory Specialists, and Regulatory Professionals, organised into three teams. We are currently managing multiple active projects that span a wide array of domains and functional areas.
Our department is charged with delivering and executing on global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.
We are responsible for driving label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, paediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations. Working at
At , 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 Paolo Voltolina at Deadline
9 June 2024. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application. 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 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.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg