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Regulatory Affairs Manager (m/f)

For our customer of the pharmaceutical industry located in Darmstadt (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 years experience in Regulatory Affairs within a pharmaceutical company, CRO or similar organization
  • Excellent English skills
  • 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 you? If so, please apply online 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 089-3840907 for your questions and further assistance!
Dr. Sarah Wälde
Kelly Scientific München
T: 089-3840907
How to apply:
CV,  cover letter
Send application to
Dr. Sarah Wälde
Kelly Scientific München
T: 089-3840907
While applying for the job please refer to jobvector and use the following reference number: JO-1509-33816

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....

More about Kelly Scientific Resources München

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