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Regulatory Affairs Manager for Austria and Switzerland (Alpine region)

  • Job
    Full-time
    Mid & Senior Level
  • Quick Apply

AI generated summary

  • You need 3-5 years in pharma/biotech, 2-3 years with Swissmedic submissions, EU knowledge, eCTD experience, and fluency in German and English. Strong teamwork and independence are essential.
  • You will manage marketing applications, coordinate with regulatory agencies, update labeling, ensure compliance, support clinical strategies, and oversee local vendors and budget.

Requirements

  • 3-5 years' experience in the pharma/biotech industry within a similar position.
  • Experience in regulatory submissions to Swissmedic (2-3 years)
  • In-depth knowledge of the regulatory framework in the Alpine region, with a focus on Switzerland
  • Strong understanding of the EU regulatory framework for centrally authorized medicinal products
  • Experience with document management, artwork and eCTD submission systems
  • Excellent interpersonal skills with a proven ability to collaborate across cross-functional teams
  • Ability to work independently and efficiently under time pressure
  • Proficiency in both German and English

Responsibilities

  • Submits marketing authorization and life cycle management applications to the Swiss Health Authority (Swissmedic), including using innovative and accelerated application procedures to expedite market access
  • Manages local implementation activities of centrally registered products
  • Coordinates Swissmedic List of Questions with the Global Regulatory Affairs team and negotiates local post-approval commitments, including submission due dates
  • Liaises with regulatory agencies as required including the coordination of NCA meetings
  • Prepares and updates labeling and artwork in compliance with regulatory requirements and internal procedures in the event of labeling changes
  • Ensures all local submission/application correspondence is appropriately communicated, filed and archived as per SOPs/policies
  • Provides input into clinical trial strategies as required
  • Participates in inspections, audits
  • Participates in Compassionate Use Program, EAP or post-trial access management
  • Manages local vendors supporting the regulatory function and plans local RA budget
  • Performs other country-specific tasks in accordance local regulatory requirements

FAQs

What is the job title for this position?

The job title is Regulatory Affairs Manager for Austria and Switzerland (Alpine region).

Who does the Regulatory Affairs Manager report to?

The Regulatory Affairs Manager reports to the Associate Director, CENE Regulatory Affairs.

Where is the job located?

The job is located in Baar, Switzerland.

What are the main responsibilities of the Regulatory Affairs Manager?

The main responsibilities include submitting marketing authorization applications, managing local implementation activities, coordinating with Swissmedic, and ensuring regulatory compliance.

What level of experience is required for this position?

The position requires 3-5 years of experience in the pharma/biotech industry within a similar position.

Is experience with Swissmedic submissions required?

Yes, 2-3 years of experience in regulatory submissions to Swissmedic is required.

What language proficiency is necessary for the role?

Proficiency in both German and English is necessary for this role.

Does the role require collaboration with other teams?

Yes, excellent interpersonal skills and the ability to collaborate across cross-functional teams are crucial for this position.

Will the Regulatory Affairs Manager participate in inspections or audits?

Yes, the Regulatory Affairs Manager will participate in inspections and audits as part of their responsibilities.

What is the company's stance on diversity and employee development?

Alexion values diversity, innovation, and connection, providing an encouraging environment where employees can grow their careers and make a meaningful impact.

What science can do

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. AstraZeneca is a global pharmaceutical company dedicated to improving the health and well-being of people worldwide. With a focus on innovative research and development, AstraZeneca develops and manufactures a wide range of prescription medicines, including treatments for cardiovascular, respiratory, oncology, and other therapeutic areas. Their aim is to transform the lives of patients by discovering, developing, and delivering innovative medicines that address unmet medical needs. AstraZeneca's purpose is to push the boundaries of science and collaborate with healthcare professionals, organisations, and communities to improve patient outcomes and contribute to the advancement of healthcare globally.