Regulatory Affairs Director for Europe based in Switzerland!
Adecco Sweden AB / Läkarjobb / Ospecificerad arbetsort
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Visa alla läkarjobb i Ospecificerad arbetsort eller i
hela Sverige Visa alla jobb hos Adecco Sweden AB i Ospecificerad arbetsort For our customer, an internationally leading biopharmaceutical company based in Central Switzerland, we are currently looking for an experienced Regulatory Affairs Director. In this challenging position you will provide leadership and strategic direction within Regulatory Affairs in collaboration with cross-functional local, regional and global teams.
Your main responsibilities
* Provide leadership and strategic direction in regulatory affairs to support the timely registration / regulatory clearance.
* Partner with senior Management, including R&D and Marketing teams, to develop and implement effective (timely, cost effective) registration strategies.
* Proactively interact with registration bodies for the purposes of negotiating cost effective and timely commercialization pathways.
* Work closely with Division Marketing and Commercial Selling organizations to facilitate prioritization and execution of registration strategies.
* Stay current and communicates important regulatory issues and requirements to Global Supply Chain management. Partner with senior Global RA/QA management peers to continuously improve and harmonize product submission processes in response to evolving requirements.
* Work with management and MarCom to implement consistent and compliant processes for the review and approval of promotional activities (print/web advertising, trade shows, scientific publications, etc.) both prior to, and following, receipt of regulatory clearances/approvals.
* Partner with Global QA teams to support domestic and international complaint reporting requirements. Include overseeing subsidiary, customer, and regulatory authority notifications for adverse events, field safety corrective actions, and other CAPA-related activities.
Requirements
* Bachelor 's Degree. Advanced degree preferred. RAC or other relevant certification desirable.
* 10 years relevant industry experience and a five years supervisory /management experience.
* Extensive knowledge of regulations with focus on European registrations.
* Proven management skills and demonstrated ability to effectively communicate (written and oral) with individuals to attain desired goals are necessary.
* Ability to effectively establish project priorities and delegate with appropriate authority.
* Ability to create, innovate, and anticipate changing needs and adapt in a timely way.
* Ability to analyze diverse scientific and regulatory issues and draw risk-based conclusions regarding the best path for introducing products to market.
About Adecco Life Science
Adecco Life Science is a specialized Business Line within Adecco. We work exclusively with Staffing Services and Recruitment of personnel within the Life Science industry. Our expertise lies within all areas of Life Science such as R&D, Production, Quality Assurance, Clinical Research, Regulatory Affairs, Medical Affairs, Marketing & Sales and many more. Our customers are companies, of different sizes, within the Pharmaceutical-, Biotech- and Medtech- industries.
Are you interested?
Since the recruitment is being done on a continual basis you should apply as soon as possible if you find the position interesting.
Unfortunately we can not accept applications through e-mail, but if you have questions regarding the position contact Heidi Pettersson,
heidi.pettersson@adecco.se.
We look forward to your application!
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2016-12-08ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-01-07
Klicka på denna länk för att göra din ansökanKontaktHeidi Pettersson
Heidi.Pettersson@adecco.seFöretagAdecco Sweden AB
AdressAdecco Sweden AB
Kungsgatan 60
10224 STOCKHOLM
KontorsadressKungsgatan 60
Jobbnummer 3202794
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