Global Regulatory Affairs – REGULATORY PROFESSIONAL
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Ballerup
Do you want to join Global Regulatory Affairs as a Regulatory Professional? Do you want to be part of a team supporting the regional and global regulatory strategy for marketed psoriasis products?
Then I strongly urge you to apply for the vacant position in my team as Global Regulatory Professional!
As Global Regulatory Professional you will work with the EU+ Lead and support the regulatory strategy for 3 marketed psoriasis products with clinical trial activities for one of them. You will perform supporting activities for the products to ensure successful optimization and commercialisation in accordance with business priorities.
You will join a department (Global Regulatory Strategy Marketed Products) of 9 dedicated and skilled regulatory strategists and professionals:
- The Regional Leads EU+ and US are responsible for the regional regulatory strategy and deliverables for LEO Pharma’s marketed products and are members of the Global Regulatory Teams (GRTs) in Global Regulatory Affairs
- The Global Regulatory Leads (project) lead the GRTs and represent the GRTs in the Life Cycle Management Teams.
Our team is based in Ballerup, Denmark and in Madison, NJ USA.
The job – roles and responsibilities
As a Regulatory Professional you:
- Will in conjunction with the EU+ Lead, manage coordination, preparation and timely submission and approval of various original and variation filings for EU+
- Ensure timely follow up and execution according to agreed timelines
- Where delegated, secure regulatory interactions and ensure submissions for regional filings while leveraging your colleagues/subject matter experts in the Global Regulatory Teams and other relevant functions
- Create Module 1 documents (e.g. Application Form and Cover letter) for submissions related to EU procedures
- Support/perform data entry in eRIMS (request form)
- Review relevant documents that will be included in regional /global regulatory applications/interactions in accordance with local and global regulatory guidance / legislation, while leveraging your colleagues/subject matter experts in the Global Regulatory Teams
- May be the primary RA representative in project sub teams and be responsible for liaising with the Global Regulatory Teams to ensure regulatory strategy and project strategy are aligned
- Act pro-actively and sustain good stakeholder collaboration within GRA and in LEO organization via continuous stakeholder management
- Represent GRA according to delegated tasks
Your qualifications
I am looking for a team player who appreciates working with deadlines both individually and with a team. You are solution and action oriented. Your professional skillset comprises:
- Master's or bachelor's degree within natural science or equivalent. Advanced degree preferred.
- Seniority within regulatory +4 years, within different kinds of regulatory activities.
What you can expect from me as your manager
I take my responsibilities as a leader very seriously! I do my best to create the best possible working environment for my team including an environment where it’s safe and acceptable to speak your mind, where we eagerly share knowledge with each other and are not afraid to share our mistakes. I wish everyone in my team is the best version of themselves, that they do their best work, and continuously develop.
About LEO Pharma
LEO Pharma is an independent research-based pharmaceutical company founded and headquartered in Denmark, currently employing 6000 professionals across 60 countries. LEO Pharma drives dermatology and helps people achieve healthy skin by supplying treatments to people with medical needs in more than 130 countries around the world.
Contact and application
If you have questions, please do not hesitate to contact me: Head of Global Regulatory Strategy Marketed Products Christina Virkelyst Tvermoes
. The deadline is 06-AUG, 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 16.7.2021, 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
- Fredag den 06. august 2021
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