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Pharmaceutical Affairs Manager (m/f)

 Alexion Pharma Germany GmbH   München
Reports to: General Manager / VP Regulatory Affairs
Location: Munich, Germany

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in more than 40 countries for the treatment of PNH, and in the United States and European Union for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris and is pursuing development of other innovative biotechnology product candidates in early stages of development. Further information about Alexion Pharmaceuticals, Inc. can be found at:

Position Summary
Acts as the official link (authorized person) with the national and local Regulatory Authorities (Government of Upper Bavaria, Paul Ehrlich Institute (PEI) and Federal Institute for Drugs and Medical Devices (BfArM)).
The Pharmaceutical Affairs Manager is responsible for regulatory compliance of drugs commercialized by Alexion Pharma in Germany with the pharmaceutical and legal regulations in accordance with the company's specifications and the applicable relevant regulations, processes and standards.

Tasks and responsibilities
The Pharmaceutical Affairs Manager is responsible for the wholesale licence pursuant to Section 52a German Drug Law (AMG) and for implementing the requirements of the German regulation governing the production of pharmaceuticals and active substances (AMWHV).
The Pharmaceutical Affairs Manager acts as the official liaison between the company and the German Regulatory Authorities (Government of Upper Bavaria, Paul Ehrlich Institute (PEI) and Federal Institute for Drugs and Medical Devices (BfArM):
  • Proper implementation of the requirements stipulated in Section 52a AMG (pharmaceutical wholesale) governing Alexion Pharma for both the German as well as other markets served by Alexion Pharma Germany.
  • Accountable for regulatory compliance to local Marketing Authorizations at all times
  • Maintenance of the Quality Management System
  • Implementation of new SOPs as requested
  • Works with regulatory agencies on a “daily basis” and manages local health authorities meetings
  • Review and approval of local labeling (translation checking)
  • Negotiates and manages local post-approval commitments
  • Regulatory submissions as needed by local requirements (e.g. GMP clearances, …)
  • Accountable for all life cycle management activities of registered products (submission of Educational Material, updated labels…)
  • Submission and management of procedure for Clinical Trial application (CTA) /Notifications (CTN)
  • Develop a strategy for preparation and submission of new Risk Management plans
  • Local implementation of post-authorization follow-up measures as required
  • Provide Training on specific regulatory requirements (e.g. controlled distribution for Soliris)
  • Provides local regulatory environment intelligence and advice anticipating regulatory hurdles
  • Approves all promotional items (incl training material) and local press releases
  • Accountable for compliance with sunshine act (where applicable)
  • Compliance with the Risk Management Plan (in particular for ensuring that the activities for dealing with identified risks approved by the regulatory authorities are implemented)
  • That training courses on SOPs, new legal regulations, etc. are carried out

In this role you will also hold the position as:
  • Information Officer pursuant to Section 74a German Drug Law (AMG)

At least 8 years' experience in the pharma/biotech industry, including experience in a similar position. Pharmacist, knowledgeable about the tasks and duties set forth in Section 74a AMG, many years’ experience in quality management in the pharmaceutical industry. Experience in launching new drugs or biotech products are preferred.
  • Excellent knowledge of local pharmaceutical regulations and thus of ethical conduct in Germany
  • Experience in cooperation with Paul Ehrlich Institute (PEI) and Federal Institute for Drugs and Medical Devices (BfArM), has a network within these authorities
  • Experience with clinical studies
  • Experience with managing a small team
  • Knowledge of pharmacovigilance regulations
  • Social skills and competencies in dealing with others as well as in working independently
  • Capability to develop and implement action plans in an independent environment
  • Very good written and spoken German and English
  • Data processing skills
  • Travel required (limited)

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. To learn more about Alexion, please visit or download our App for iPhones and Blackberries.
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To learn more about Alexion, please visit or download our App for iPhones and Blackberries.
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