Arbejde Regulatory Integration Specialist - Submission Management unspecified LEO PHARMA A/S - jobtilbud
reference: 4959515
documentId: 4959515
connectionPointId: 7
lastModificationDate: 1552479472246
stillingsbetegnelse:
Regulatory Integration Specialist - Submission Management
jobbeskrivelse:
Do you want to make a difference in a challenging position? Join our Project Team for a business-critical project in LEO’s Global Regulatory Affairs
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. Following a major acquisition, we are creating a project team to drive the integration of the MA transfers – a task that will be fast-paced, dynamic and challenging.
In the RA Submission Project Team, you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. We are recruiting for a 12-month position, with vacation restrictions from week 24 to 29. Preferable start as soon as possible.
The job
As a Regulatory Integration Specialist, you will be working with the transfer of a large product portfolio, ensuring that LEO takes over regulatory responsibilities. Since the product portfolio is already marketed there are ongoing submissions and transfer activities. You will be involved in the development and execution of processes, working to tight deadlines.
- Submission of MA transfers across the world according to business plan.
- Communication with Local Regulatory people to ensure submissions.
- Ensuring communication regarding the MA transfers are done to all stakeholders at the right time.
- Identifying obstacles and issues and working with stakeholders to quickly find solutions.
- Transfer of data to the data integration team.
- Guidance and support to the data integration team.
Your qualifications
- Relevant master’s degree and/or bachelor’s degree, or similar work experience.
- Experience with or knowledge of Regulatory Affairs or related functions such as CMC, Clinical, Pharmacovigilance or Manufacturing within the pharmaceutical industry.
- Some project management experience including communication, collaboration and planning, able to multitask effectively.
- Experience interacting with different people across an organisation and across cultures.
- Able to quickly identify and find solutions to problems. Applies creative thinking to overcoming obstacles.
- Fluent in written and spoken English.
People know you for being proactive and result-driven, as well as for your ability to take ownership. You are great at analysing and finding solutions, while being open to new ideas and inputs from others. You have a good eye for details without losing the view on the big picture. You are an excellent collaborator and communicator and have ability to motivate others to adapt to to new processes and understand how to build efficient working relationships with both internal and external stakeholders.
About Regulatory Affairs Submission Management
The RA Submission Project Team is a part of RA Submission Management Department consists of approx. 38 dedicated and skilled colleagues across 3 teams (2 in Denmark and 1 in Ireland) This position are in headquarters in Ballerup, Denmark. You will be working in a special project team reporting to the line of Submission Management.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application deadline
For further information, please contact Jette Wessel on +45 40 33 93 20
Please submit your application and CV in English as soon as possible.
Job interviews will be held on a continuous basis.
We look forward to receiving your application.
numberOfPosts: 1
jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421
abstractJV_contact_0: Please apply using one of the specified channels
positionTypeCode: directhire
contractTypeCodes_0: fulltime
Arbejdsgiver Navn: LEO PHARMA A/S
source: DK-STAR
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