Regulatory Affairs Specialist, RA Obesity
Søborg
Are you passionate about regulatory science and driving innovative regulatory strategies to bring innovative medicines to patients? Do you have strong scientific background combined with regulatory drug development experience? Do you want to play a pivotal strategic role in developing and executing the late-stage regulatory strategy for one of our key projects?
If yes, then we encourage you to submit your application to become part of a team of dedicated professionals working on one of our key projects within Regulatory Affairs (RA). We are currently expanding as the project progresses rapidly towards End-of-Phase 2 interactions and initiation of phase 3 development in multiple indications within obesity, diabetes, and other related conditions. T ake the next step and apply now!
The position
As a Regulatory Affairs Specialist, you will lead the development of the regulatory strategy for one or more indications and be responsible for driving several regulatory tasks with challenging and often overlapping timelines.
This position requires close collaboration with the Global Regulatory Lead to shape the regulatory strategy. Additionally, it necessitates engagement with key cross-functional stakeholders. The role offers great breadth of responsibility, complexity, and development opportunities, and you will contribute to the project direction and decisions.
Your key responsibilities will include: Provide strategic input and regulatory expertise to the project development plan; lead the development of the regulatory strategy for the assigned indication, evaluate regulatory risks and recommend mitigation strategies Interact with internal and external stakeholders and represent Global Regulatory Affairs in regulatory matters across different cross-functional teams Plan, prepare and lead interactions with Health Authorities Lead the development of regulatory documentation, such as briefing packages for Health Authority interactions, paediatric plans, clinical trial applications and labeling documents Mentor junior colleagues and share your expertise to support their professional development 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: An academic degree such as master’s degree and/or a Ph.D. within Life Science, Health Science, or a related field Extensive regulatory experience working on global drug development programs (6-7 years) Proven track record of interacting directly with regulatory authorities on an international scale such as FDA or EMA Strong negotiation and stakeholder management skills and a sound understanding of business and data Fluent written and spoken English On a personal level, you thrive in collaborative team settings, demonstrating strong leadership and contribution to team achievements. You should exhibit excellent organisational skills, robust problem-solving abilities, and maintain a strategic focus. A positive, can-do attitude is essential, along with the capacity to maintain composure and a sense of humour in high-pressure situations. Proficiency in effective communication to facilitate collaboration across all organisational levels is highly valued.
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 Lene Ejstrup Sørensen 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 yes, then we encourage you to submit your application to become part of a team of dedicated professionals working on one of our key projects within Regulatory Affairs (RA). We are currently expanding as the project progresses rapidly towards End-of-Phase 2 interactions and initiation of phase 3 development in multiple indications within obesity, diabetes, and other related conditions. T ake the next step and apply now!
The position
As a Regulatory Affairs Specialist, you will lead the development of the regulatory strategy for one or more indications and be responsible for driving several regulatory tasks with challenging and often overlapping timelines.
This position requires close collaboration with the Global Regulatory Lead to shape the regulatory strategy. Additionally, it necessitates engagement with key cross-functional stakeholders. The role offers great breadth of responsibility, complexity, and development opportunities, and you will contribute to the project direction and decisions.
Your key responsibilities will include:
To be a competitive candidate you should have:
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 Lene Ejstrup Sørensen 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