Dr. Karen Rosenkranz

Berufserfahrung von Karen Rosenkranz

• Bis heute 10 Jahre und 10 Monate, seit Sep. 2013

  Associate DIrector - Gobal Regulators Affairs Labeling

  Merck KGaA

  Global labelling within a cross-functional team: Compilation and maintence of CCDS and CSI, supervising of implementation into regional and national product information

• 5 Monate, Apr. 2013 - Aug. 2013

  Leitung Zulassung DACH

  Norgine GmbH

  All life-cycle maintenance activities for chemical-defined products (MR-product and national licence) including local regulatory submission strategy in the DACH-region; Strategic advice to local marketing an market access; accountable of of 3 direct reports Overseeing of all labelling activities including approval of packaging materials

• 5 Jahre und 8 Monate, Aug. 2007 - März 2013

  Drug regulatory affairs manager

  Grifols Deutschland GmbH

  Life-cycle activities for blood products EU wide, regulatory submission strategy, scientific advice national and EMS, Orphan Drug designation applications, scientific advice procedures at national authorities and EMA, Regulatory Intelligence

• 1 Jahr und 11 Monate, Okt. 2005 - Aug. 2007

  Drug regulatory affairs manager

  Merck Deutschland

  Dealing with renewals according § 105 of German Drug Law as well as responses to clinical and quality deficiency letters from the authority, Labeling, submission strategies

• 4 Jahre und 4 Monate, Juni 2001 - Sep. 2005

  Drug safety & regulatory affairs manager

  Baxter

  Drug safety, QA, PSUR, CCDS, oncology, Labeling, regulatory maintenance activities

• 2 Jahre, Juni 1999 - Mai 2001

  Medical Manager

  TEMMLER

  Scientific information in the area of metabolic and neurological disorders; EU arbitration procedures (‘Anorextica procedures’), Compilation of PSUR and expedited reports; Product manager for the anti-obesity drugs Regenon® and Regenon® retard: implementing marketing strategies, training of the sales force