Head of Regulatory Affairs Operations - Zurich

Ort: Switzerland - Glattbrugg/Zurich

Funktion: Regulatory Affairs

Firma: Vifor Pharma

Senioritätslevel: Director

Thomas Lemercier

International Talent Acquisition Manager

+41 58 851 82 73

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Ihr Profil

We are currently looking for a Head of Regulatory Affairs Operations to join our Regulatory Affairs team. This role reports directly to the Head Regulatory Affairs Center of Excellence and is planned to be based in Zurich. Your responsibilities will include:
  • Oversee operational projects and related resources to achieve business objectives and priorities within Regulatory Operations: specific focus on electronic document management, records and data management, electronic regulatory submissions and submission tracking.
  • Proactively work with Regulatory Affairs, Nonclinical, Clinical, CMC and Safety groups from the initial process of defining regulatory requirements and strategies to the final approval of reports and their inclusion in the regulatory dossiers.
  • Interface with internal departments to ensure timely submissions and to oversee the support of global filings as Regulatory Operations representative on submission teams.
  • Prepare and manage plans for each regulatory submission and report submission updates against milestones (identify areas of risk of jeopardizing the timeline and identify areas of resolution to timeline issues).
  • Ensure the use of appropriate document policies and standards to create “Regulatory Submission Ready” documents to facilitate rapid review and approval of the submission by regulatory authorities by creating and promoting the standardization of submission processes within the company (including creation of explanatory documents, style guides, etc.).
  • Communicate with external contractors to inform them of technical requirements for source documents through the provision of templates and company policies and standards.
  • Direct the logistical details in generating regulatory submissions, including the identification and sourcing of appropriate tools.
  • Coordinate updates & problem solving issues related to publishing software; rollout of new functionality and work processes within GRA
  • Manage and lead the people, processes and technology required to facilitate the production and management of the regulatory submissions and records and data management: includes resource management, team composition and communication 
  • Train and develop staff.
  • Manage budget for Regulatory Operations team.
  • Maintain knowledge of Regulatory submissions requirements and communicate new developments with potential business impact internally, driving and implementing process changes accordingly.
  • Support planning and preparation for communications and meetings with regulatory authorities, as needed 
In addition, you will bring the following profile:
  • A minimum of 10 years’ experience in managing the preparation of regulatory dossiers in the pharmaceutical industry (including NDA, NDS, MAA, IND, CTA etc.).
  • Experience of attending Agency meetings and managing the logistics.
  • A good understanding of emerging global regulatory requirements and technology developments 
  • Familiarity with the document requirements of ICH/GCP and other regulatory guidances appropriate for preparation of dossiers 
  • Fluent in English
  • Team management experience
  • Strong IT background

Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/ueber-vifor-pharma/wer-wir-sind

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