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Regulatory Affairs Manager (m/f)

For our customer of the pharmaceutical Industry located in the Rhine-Main Area (Hesse), we are looking for a talented

Regulatory Affairs Manager (m/f)
 
Activities include:
  • Responsibly for achieving assigned global regulatory milestones and for regulatory compliance by timely, in good quality and properly documented submission of labeling changes, quality related changes, Periodic Safety Update Reports (PSURs)
  • Application for new marketing authorizations, line extensions and new indications, renewals in order to keep marketing authorizations valid
  • Provide information on RA milestones to global RA and other functions (Medical, Pharmacovigilance, Product Supply, Business, etc.)
  • Early identification of major regulatory issues relating to clinical, technical, strategic or operational information impacting marketing authorizations applications/approvals for assigned projects
  • Communication and Management of regulatory measures in all major global markets via the regulatory core team members and/or local regulatory departments
 
Required profile:
  • Degree or PhD in Life Sciences, Pharmacy or a closely related discipline. The additional qualification as “Master of Regulatory Affairs” would be of advantage.
  • At least 2-5 year’s experience in Regulatory Affairs within a pharmaceutical company, CRO or similar organisation
  • Excellent command in English as a business language
  • Applicants should be proactive, team-orientated, self-motivated and capable of working independently, with excellent organisational skills and attention to detail
 
Does all of this sound interesting and challenging for your? If so, please apply online on www.kellyservices.de for this great opportunity. You only need your name, address, email-address and your CV to register within three minutes. All other documents will be on request! Do not hestitate to contact us by phone 069 2440 40 23 for your questions and further assistance!
 
Xenia Becker
Kelly Services GmbH – Division Kelly Scientific Resources
T: 069 – 2440 40 23
 
About Kelly
It's more than a job. It's passion.
Wir bei Kelly Services wissen, dass Menschen der Schlüssel zum Geschäftserfolg sind. Unsere Leidenschaft ist es, Talente zu entdecken und ihre persönliche und berufliche Entwicklung voranzubringen. Denn Teil des Kelly Teams zu sein bedeutet, diejenigen zu verstehen, mit denen wir arbeiten, eine langfristige Beziehung aufzubauen, zu inspirieren und zu beraten. Sowohl unsere Mandanten als auch die Menschen, die wir jeden Tag auf Ihrem Karriereweg begleiten.

How to apply:
Online or by E-Mail
Send application to
Xenia Becker
Kelly Services GmbH – Division Kelly Scientific Resources
T: 069 – 2440 40 23
E-Mail: xenia.becker@kellyservices.de
While applying for the job please refer to jobvector

About Kelly Scientific Resources München

Unsere Berater und Manager im Fachbereich Kelly Scientific Resources - alle ebenfalls ausgebildete Naturwissenschaftler mit langjähriger Berufserfahrung - widmen sich mit ihrer Fachkenntnis ausschließlich der Identifizierung, Beratung und Vermittlung von naturwissenschaftlichem und medizinischem Fach- und Führungspersonal in einem breiten Spektrum von Branchen und Berufsfeldern....

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