Regulatory Professional
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Ballerup
Are you eager to step into Global Regulatory Strategy, and are you looking for a unique opportunity to further you career?
In Global Regulatory Affairs we are looking for two Regulatory Professionals to help us build regional regulatory knowledge base and to deliver day-to-day regulatory strategy as directed by regional and/or global regulatory leads. One of the vacancies is a 1-year temporary position whereas the other is a permanent position – in your application, please indicate which you are interested in. You will join a small group of dedicated and skilled strategists. We are responsible for creating and driving regulatory strategies for successful optimization of projects/products in accordance with business priorities. We are based in Ballerup, Denmark and in Madison, NJ USA.
The job
The vacancies are located in Global Regulatory Strategy and as a Regulatory Professional you will support the regulatory strategies for the projects/products you are assigned to and ensure there is a sound regulatory foundation for the successful optimization of the LEO Pharma assets in accordance with business priorities. You should expect to work in other groups of Global Regulatory Strategy as needed.
As Regulatory Professional in Global Regulatory Affairs at LEO Pharma A/S, your responsibilities include:
- Supporting regulatory activities for the development and commercialization of projects and products within the LEO Pharma portfolio.
- Supporting regional lead and/or global regulatory lead in project sub-teams and liaising with the global regulatory teams to ensure regulatory strategy and project strategy are aligned.
- Securing/driving regulatory interactions and submissions, with strategic and operational support accountability for the regional filings (e.g., Module 1 content) while leveraging regulatory subject matter experts and other functions where needed.
- Reviewing relevant documents that will be included in regional /global regulatory applications/interactions in accordance with local and global regulatory guidance / legislation, as applicable, while leveraging subject matter expertise.
- In conjunction with the regional lead and/or global lead, managing coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs) for their region, working in a global collaborative manner. Ensure timely follow up and execution according to agreed timelines.
Your qualifications
We are looking for a team player with a global mindset, who is eager to learn and has a ‘can-do’- attitude. You think locally and act globally – and you think globally and act locally. Your professional skillset comprises:
- Master's or bachelor's degree within natural science or equivalent. Advanced degree preferred.
- +3 years’ experience with regulatory, within different kind of regulatory activities.
- Working knowledge of the regulatory framework on a regional level in development- and/or life cycle management phases of drug development.
- Ability to interpret guidelines and give recommendations for day-to-day regulatory strategic activities.
Contact and application
If you have questions, please do not hesitate to contact Dorte Villumsen, Senior Global Regulatory Lead, Global Regulatory Strategy – Innovative 3 at [email protected] or + 45 3119 2127.
. The deadline is March 11, 2021.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 25.2.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Ballerup
- Torsdag den 11. marts 2021
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