Senior Advisor Regulatory Affairs, SDS Life Science
Search4S Dustgoat AB / Administratörsjobb / Danderyd
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hela Sverige Can you set up regulatory strategies for drugs on or near the market, e.g. in terms of market approval, variations, new indications or formulations? Do you want to support pharmaceutical companies in developing smart regulatory strategies and the right documentation? SDS Life Science is a leading consultancy within drug development in the Nordic market. We are now developing in later phases of the life cycle. You will be a part of an entrepreneurial culture where you can have great impact and future leadership opportunities.
Does it sounds good? Take a closer look at the position as Senior Advisor!
As a Senior Advisor at SDS Life Science, you work from one of our offices with advice and operational support to our customers within pharma. As a consultant, you can both work in teams with several colleagues or independently with a project, but you are never alone. Your own expertise is the key to providing results, as well as continuously expanding your knowledge .
Here are some examples of typical assignments you might get:
Coordinate and lead the work with applications for marketing authorization, mainly national applications and DCP.
Be a regulatory expert, together with other experts at the company, in matters concerning products such as new formulations, variations, changes in SmPC for existing product and/or generics.
Lead the work with new products with known substance and also WEU applications
Act as a regulatory adviser in scientific advice with national authorities and EMA
Stay up to date on requirements and regulations within the Nordic region, EMA, FDA and Asia.
Regulatory responsible for clinical trial applications.
You will work with different companies, therapy areas, product types and processes. At SDS Life Science, every colleague is important and the future looks bright.
Here is a short movie about working at SDS Life Science (Swedish):
https://www.sdslifescience.com/wp-content/uploads/2020/05/SDS_film.mp4www.sdslifescience.comLocation: Uppsala or Stockholm.
Terms: Full-time, or part-time. The employment is for the time being with SDS Life Science as employer.
Start date: As soon as possible or upon agreement
Qualifications:
Several years of experience of working with regulatory affairs at a pharmaceutical company, as a consultant or within a medical product agency.
Regulatory expertise in issues related to e.g. new formulations, variations, changes in SmPC for existing product and / or generics.
Experience from coordinating and leading the work with marketing authorization applications, mainly national applications and via DCP, preferably also CP
Good knowledge of EU regulations
Experience of regulatory work for products late phase and / or after market approval.
Experience of clinical trial application.
Great written and spoken English
Good Swedish in speech and writing is a strong merit. Experience from scientific advice is meriting.
As a Senior Adviser, you need to understand the bigger picture of regulatory processes to be able to guide others in strategic choices. You enjoy the variation in the daily work, such as writing, leading discussions and projects, searching for information and setting up strategies. You are the one who find solutions where others see problems!
Does this sound like you? Welcome with your application!
Application and more information
In this recruitment, SDS Life Science works with Search4S. Interviews and selections may take place on an ongoing basis. For more information, contact Recruitment Consultant Anna Rennermalm, +46 70 794 20 05 or
anna@search4s.se.
Please note that the application is sent through a web link and not via email.
Application deadline: 22 Nov 2020
About SDS Life Science
SDS Life Science is a leading consulting company in the Nordic region. We are focused on the development of pharmaceuticals and medical devices. Our most important asset is our staff, where everyone has extensive experience of product development from the pharmaceutical / medtech / biotech industry, government agencies and / or academic research. We can therefore offer our customers a unique overall concept consisting of both specialist competence and the overall responsibility for certain parts of or alternatively an entire project.
We are ca 50 consultants located in Stockholm, Uppsala, Gothenburg and Oslo and are rapidly growing.
www.sdslifescience.sePubliceringsdatum2020-10-27Så ansöker duSista dag att ansöka är 2020-11-22
Klicka på denna länk för att göra din ansökanAdressSearch4S Dustgoat AB
Svärdvägen 23
18233 DANDERYD
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Search4S Dustgoat AB (org.nr 559065-9297)
Svärdvägen 23 (
visa karta)
182 33 DANDERYD
Arbetsplats SDS Life Science
Jobbnummer 5420440
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