Regulatory Affairs Manager for Austria and Switzerland (Alpine region)

at  AstraZeneca

DETAILED ACCOUNTABILITIES:

• 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

Other accountabilities:

• 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

CRUCIAL SKILLS/EXPERIENCE:

• 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

The Regulatory Affairs Manager works under the responsibility of the Associate Director, CENE Regulatory Affairs to ensure regulatory compliance of drugs commercialized by Alexion in the Alpine region (incl. Liechtenstein) in accordance with the applicable relevant regulations, processes, and standards.
The Regulatory Affairs Manager acts as the link between Alexion and the National Competent Authority (NCA) on all regulatory submissions and discussions in the Alpine region, as well as other stakeholders inside and outside Alexion.
The Regulatory Affairs Manager is responsible for regulatory compliance of Alexion’s authorised products in line with all applicable regulations as well as in line with the company’s SOPs/policies.