Regulatory Affairs Manager for Austria and Switzerland (Alpine region)

Reports to: Associate Director, CENE Regulatory Affairs

Location: Baar, Switzerland

Introduction to Role:

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.

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 accessManages local implementation activities of centrally registered productsCoordinates 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 meetingsPrepares 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 requiredParticipates in inspections, auditsParticipates in Compassionate Use Program, EAP or post-trial access managementManages local vendors supporting the regulatory function and plans local RA budgetPerforms 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 SwitzerlandStrong understanding of the EU regulatory framework for centrally authorized medicinal productsExperience with document management, artwork and eCTD submission systemsExcellent interpersonal skills with a proven ability to collaborate across cross-functional teamsAbility to work independently and efficiently under time pressureProficiency in both German and English

Why join us?

At Alexion, AstraZeneca Rare Disease, we push the boundaries of science to transform complex biology into life-changing medicines. Our dedication to patients drives us to innovate continuously. With a rapidly growing portfolio, we offer an entrepreneurial spirit combined with the resources of a global biopharma. Join us to make a meaningful impact on patients' lives while growing your career in an encouraging environment that values diversity, innovation, and connection.

Ready to make a difference? Apply now!

Date Posted

28-Jan-2025

Closing Date

26-Feb-2025

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. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.