Medior Regulatory Affairs Ops Specialist
Modis Sweden AB / Kemiingenjörsjobb / Lund
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hela Sverige Modis Life Science is looking for a Regulatory Affairs Specialist to a pharmaceutical company in Lund. This is a 1 year full-time consultancy assignment.
For this assignment, the customer is requesting a medior level consultant. If you have the requested background, register and send your CV and application as soon as possible.
The primary responsibilities of this position include the following:
* Support Global Regulatory Lead in ongoing major projects
* Directly communicate with RA team members to develop global regulatory project plans, including a detailed list of submission deliverables, dependencies, approval timing and cost.
* Compile regulatory documentation in support of medical device and drug submissions in accordance with local regulatory requirements.
* Create / maintain overall schedule for global registration activities, and communicate accomplishments and risks to global project team.
* Coordinate responses to regulatory authority queries with strict deadlines.
* Support Country RA to maintain and update existing regulatory authorizations
* Prepare / update product labeling (i.e., create red-lines, route documents through review / approval process).
* Perform regulatory assessment on changes and support ongoing activities in accordance with the company 's processes
Requested skills:
* Written and verbal communication skills in English
* Ability to manage complex / multiple projects and deadlines effectively
* Ability to identify risks and escalate when necessary
* Negotiation skills
* Past experience supporting global Medical Device registrations; Pharmaceutical regulatory experience is advantageous
* Scientific knowledge
* Technical system skills (e.g. word processing, spreadsheets, Microsoft Project, databases, online research, SharePoint)
* Project Management experience
Education:
* Bachelor 's degree or country equivalent in engineering, chemistry, or related scientific discipline with a minimum of 5 years regulatory or equivalent experience within a medical device or company similar organization.
For questions, please contact Cecilia Larzon (
cecilia.larzon@modis.se)
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2019-04-15ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-05-14
Klicka på denna länk för att göra din ansökanKontaktCecilia Larzon
FöretagModis Sweden AB
AdressModis Sweden AB
Postgatan 28
41110 Göteborg
KontorsadressPostgatan 28
Jobbnummer 4732803
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