Senior Specialist Regulatory Affairs for Austria and Switzerland (Alpine Region)
Senior Specialist Regulatory Affairs for Austria and Switzerland (Alpine region)
Reports to: Associate Director, CENE Regulatory Affairs
Location: Baar, Switzerland
Position Summary
The Senior Specialist Regulatory Affairs 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 Senior Specialist Regulatory Affairs 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 Senior Specialist Regulatory Affairs 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.
Core 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
- Ensures regulatory compliance for all Marketing Authorizations in line with all applicable regulations and Alexion´s SOPs/policies
- May act as the strategic partner to the EU Lead, International Lead, or Regulatory Project Management to define the expansion strategy and ensure compliance with Swiss regulatory requirements, facilitating timely submissions, approvals, and product launches in the market
- Submits educational materials to the NCA for approval and negotiates distribution methods in accordance with local requirements; the distribution of materials is managed per local dissemination plans and applicable SOPs
- Ensures compliance with the controlled distribution of Alexion products and annual vaccination reminders according to the RMP as required.
- 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
- Supports the Global labelling team to ensure that local labels are compliant with the Company Core Data Sheet or deviation documentation as required by internal procedures
- Prepares and updates labeling and artwork in compliance with regulatory requirements and internal procedures in the event of labeling changes.
- Manages SOPs, change controls and deviations owned by regulatory within the quality management system (QMS) and ensures that all regulatory processes and procedures are appropriately documented; where required, acts as subject matter expert (SME)
- Ensures all local submission/application correspondence is appropriately communicated, filed and archived as per SOPs/policies
- Reviews local promotional and non-promotional items according to applicable SOPs/policies
- Monitors local regulatory environment intelligence and advises GRA on the local regulatory impact
- Plans local RA budget
- Manages local vendors supporting the regulatory function
- Invoice and PO management
Other Responsibilities
- Provides input into clinical trial strategies as required
- Participates in inspections, audits
- Participates in Compassionate Use Program, EAP or post-trial access management
- Provides training on specific regulatory frameworks
- Performs other country-specific tasks in accordance local regulatory requirements
Qualifications
3-5 years' experience in the pharma/biotech industry within a similar position.
- Mandatory experience in regulatory submissions to Swissmedic (at least 2-3years)
- 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
- Fluent in both German and English
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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