Senior Manager Regulatory Affairs (gn)

Sie bringen min. 5 Jahre Erfahrungen im Bereich Regulatory Affairs mit und suchen dem Sprung zu einem namhaften Biotech-Unternehmen in München? Dann dürfte folgende Stelle bestimmt sehr interessant für Sie sein:

Senior Manager REGULATORY AFFAIRS


With considerable independence, lead regulatory activities for assigned products and topics

* Manage all activities needed to ensure compliant labeling for medicinal products in the country (SmPC, PIL, packaging) and manage timely updates for assigned product(s)
* Handles Translation Review of German Annexes associated with variations related to centrally approved Marketing Authorizations (MAs)
* Responsible for review and approval of promotional material for the assigned medicinal products
* Management of quality defects, falsified or counterfeit products for assigned products
* Manages or contributes to regulatory submissions to local Health Authority (HA)
* Support to ensure compliance with relevant national legislation and regulation and consistency with global procedural documents
* Monitor competitor regulatory information such as approvals, changes in label and other relevant local details
* Provides regulatory strategic input to local brand teams and other internal working parties
* Play an active role in ad hoc special projects that continuously improve or otherwise advance Regulatory Affairs capabilities impacting the working of the Regulatory Affairs functions

Knowledge, Experience & Skills

* University degree or comparable education preferably in Natural Sciences, Medical Sciences or Pharmacy
* Significant experience (6+ years) in Affiliate RA role and regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements
* Knowledge of Medicinal Products Act in general and further legislation (AMG, AMWHV, HWG, GCP-Regulation, Clinical Trial Directive & CT Regulation etc), GDP, GMP
* Teamwork, analytical thinking, organization skills and ability to work on a number of projects with tight timelines is required
* Excellent verbal and written communication skills (German and English) organization skills and interpersonal communication skills required


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