Regulatory Professional within Submission Excellence
Søborg
Are you motivated by working with global regulatory submissions in an international environment bringing innovative treatment to patients worldwide? Do you have a flair for planning, coordinating and for navi-gating in IT platforms? Then we offer you this great opportunity to join the Regulatory Affiliate Support department within Submission Excellence. Apply today for a life-changing career! The position
As a Regulatory Professional, you will play a central role in planning, coordinating, and executing national registration file documentation for submissions to health authorities worldwide. Your responsibilities will include: Acting as a central point of contact for affiliates and ensuring fast submissions and approvals by assessing regulatory requirements and local regulations Executing of national registration file documentation such as export certificates and statements as well as product samples, critical for submissions to health authorities worldwide Coordinating and monitoring upcoming submissions across the department, providing high-level planning and initial assessments Working in a fast-paced environment and collaborating effectively with people across the organi-zation, demonstrating cultural awareness and leadership skills Bringing forward regulatory insight, actively participating in discussions and stakeholder interac-tions Qualifications
To succeed in this role, we expect you to have: A master’s degree in a relevant field such as life or health science, pharmacy, or business Approximately 3 years of relevant work experience within the pharmaceutical industry, preferably regulatory affairs Hands-on experience working with high-level regulatory submissions (planning, assessing and ex-ecution) Business and process orientation with excellent communication skills and fluent English both ver-bal and written Experience working with Veeva Vault platform will be a strong advantage
On a personal note, you are a dedicated team player, possess excellent communication abilities and a proactive, solution-oriented mindset. You are a flexible and change-ready person who likes to experiment and sees opportunities rather than limitations in challenging situations. It is imperative that you are well organized, can handle tight deadlines, and manage multiple assignments without losing track. You have strong analytical skills and problem-solving capabilities and address your responsibilities with decisiveness and a positive mind-set. About the department
Regulatory Affiliate Support is part of the Submission Excellence area in Regulatory Affairs CMC & Devices which is one of the two head quarter based regulatory functions. In Regulatory Affiliate Support we are responsible for the additional regulatory documents process obtaining national documentation, in compli-ance with health authority regulations, to worldwide submissions, and have the privilege of working across product portfolio. We collaborate with many stakeholders across the organization such as other regulatory areas, global affiliates, Product Supply and Supply Chain. We are 13 dedicated and highly engaged employees in the department with diverse background and ex-perience. In Regulatory Affiliate Support we seek continuously to improve our processes to support fast submissions and approvals, and to ensure compliance with the global regulatory landscape which is con-stantly changing. The atmosphere is informal, and a good sense of humour is always welcome. Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dy-namic 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 de-velopment to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Tina Lindquist at +. Deadline 9 June 2024. 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.
As a Regulatory Professional, you will play a central role in planning, coordinating, and executing national registration file documentation for submissions to health authorities worldwide. Your responsibilities will include:
To succeed in this role, we expect you to have:
On a personal note, you are a dedicated team player, possess excellent communication abilities and a proactive, solution-oriented mindset. You are a flexible and change-ready person who likes to experiment and sees opportunities rather than limitations in challenging situations. It is imperative that you are well organized, can handle tight deadlines, and manage multiple assignments without losing track. You have strong analytical skills and problem-solving capabilities and address your responsibilities with decisiveness and a positive mind-set. About the department
Regulatory Affiliate Support is part of the Submission Excellence area in Regulatory Affairs CMC & Devices which is one of the two head quarter based regulatory functions. In Regulatory Affiliate Support we are responsible for the additional regulatory documents process obtaining national documentation, in compli-ance with health authority regulations, to worldwide submissions, and have the privilege of working across product portfolio. We collaborate with many stakeholders across the organization such as other regulatory areas, global affiliates, Product Supply and Supply Chain. We are 13 dedicated and highly engaged employees in the department with diverse background and ex-perience. In Regulatory Affiliate Support we seek continuously to improve our processes to support fast submissions and approvals, and to ensure compliance with the global regulatory landscape which is con-stantly changing. The atmosphere is informal, and a good sense of humour is always welcome. Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dy-namic 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 de-velopment to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Tina Lindquist at +. Deadline 9 June 2024. 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