Global Regulatory Affairs – REGIONAL LEAD EU+
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Ballerup
Are you passionate about regulatory affairs and do you want to create and drive the regional regulatory strategy for marketed products in EU+? If YES - I strongly urge you to apply for the vacant position in my team as Regional Lead EU+ Topical Psoriasis.
As Global Regulatory Regional Lead EU+ Topical Psoriasis you will create and drive the regional regulatory strategy for two marketed products. You will ensure there is a sound regulatory foundation for the successful optimisation of the products in accordance with business priorities while working closely with local RA to ensure alignment with the global strategy.
You will join a department (Global Regulatory Strategy – Established) of 9 dedicated and skilled regulatory strategists:
Our team is based in Ballerup, Denmark and in Madison, NJ USA.
The job – roles and responsibilities
As a Regional Lead EU+ you will be:
Your qualifications
I am looking for a team player with a global mindset; you think locally and act globally – and you think globally and act locally. Your professional skillset comprises:
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 - Established Christina Virkelyst Tvermoes at [email protected]
Please note that interviews will be held on a running basis and may therefore be held before application deadline.
. The deadline is 05.04.2021
As Global Regulatory Regional Lead EU+ Topical Psoriasis you will create and drive the regional regulatory strategy for two marketed products. You will ensure there is a sound regulatory foundation for the successful optimisation of the products in accordance with business priorities while working closely with local RA to ensure alignment with the global strategy.
You will join a department (Global Regulatory Strategy – Established) of 9 dedicated and skilled regulatory strategists:
- 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 GRTs are led by a Global Regulatory Lead who represents the GRTs in the cross functional Life Cycle Management Teams.
Our team is based in Ballerup, Denmark and in Madison, NJ USA.
The job – roles and responsibilities
As a Regional Lead EU+ you will be:
- Primary RA representative and responsible for EU+ in relation to overall product/project strategy including pre-clinical and clinical (working with local RA where required). You will have knowledge of the Core dossier.
- Responsible for the EU+ regulatory strategy and ensuring alignment with commercial plans and priorities to optimize portfolio
- Responsible for regulatory interactions and submissions, with strategic accountability for the regional filings
- Managing coordination, preparation and timely submission and approval of various original and variation filings (e.g., CTAs, MAAs) in EU+, working in a global collaborative manner
- Maintaining expert knowledge of the region and ICH guidance and familiarity with EMA regulations including Competitor intelligence/landscape
- Providing clear and valid regulatory guidance, interpretation by applying ‘out of the box thinking’ mind set and direction to the GRT and local RA in EU+
- Acting pro-actively and sustain a good stakeholder collaboration both within and outside Global Regulatory Affairs via continuous stakeholder management
- Providing budget input for regional plans based on Life Cycle Management strategy and goals
Your qualifications
I am looking for a team player with a global mindset; you think locally and act globally – and you think globally and act locally. Your professional skillset comprises:
- Master's or degree within natural science or equivalent
- Seniority within regulatory +5 years with relevant regulatory activities and regulatory framework on a global level, which preferably includes regulatory strategic experience.
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 - Established Christina Virkelyst Tvermoes at [email protected]
Please note that interviews will be held on a running basis and may therefore be held before application deadline.
. The deadline is 05.04.2021
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 17.3.2021, 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
- Mandag den 05. april 2021
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