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

Date Posted

11-Oct-2024

Closing Date

30-Dec-2024

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.

The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.

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