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Manager Regulatory Affairs - Swiss Affiliate (for a 6 months mission)

100% 18.02.2019
Manager Regulatory Affairs - Swiss Affiliate (for a 6 months mission)
On behalf of our client, a biomedical pharmaceutical company, we are looking for an experienced

Manager Regulatory Affairs - Swiss Affiliate (for a 6 months mission)

Job Overview

We are looking for a Manager Regulatory Affairs to serve as a core member of the Swiss Affiliate Regulatory Team
interacting with local Regulatory Authorities and other stakeholders

To ensure that Gilead complies with country's applicable legislations and regulations linked to the Marketing
Authorization (MA) / local license as MA Holder
To ensure that the medicinal products in his/her responsibility can be developed, authorized and maintained on the
To serve as a core member or to possibly lead project teams locally and to possibly lead local initiatives. May also
participate in above country teams

Job Responsibilities

Manages or contributes to regulatory submissions to local Health Authority (HA), including assisting with/leading key
aspects of initial MA application, assisting with/leading variations, safety reports, risk minimization measures, Dear
Healthcare Provider Communications, compassionate use, early access, license renewals as well as clinical trial
applications and amendments, which may require extensive interaction with departments outside of Regulatory Affairs (RA)
Ensures compliant labeling for Gilead medicinal products and manage timely updates for assigned product(s)
Support country/national scientific advice and / or pre-submission meeting preparation and follow-up
Contributes to strategic regulatory advice, as appropriate
Manages interactions, negotiations and communication with local HAs and acts as the main point of contact for the
local HAs for specific topics/products under their responsibility
Helps ensure compliance with local law and regulation and consistency with global procedural documents including
acting as a subject matter expert or assisting with the execution of audits and inspections within the affiliate
Initiates or supports local process improvements and contributes to local and/or global process improvements which
have a significant impact for RA and other departments, assesses proposed changes to local procedural documents and
impact on existing processes
Supports maintenance of GDP license and Quality Agreements, as required
Support the management of quality defects, falsified or counterfeit products, batch recalls and stock out as required
Deputy Responsible for promotional material review / approval if applicable for assigned product(s)
Supports local Affiliate, regional, Intl or Global RA teams on Affiliate matters
May support risk assessments on specific local regulatory issues
Helps prepare the Company for major changes in regulatory legislation and competitor information in the country for
assigned product(s) or projects and communicates this internally to stakeholders
Represents Regulatory Function at internal and external meetings or internal working parties
Manage or support work in additional countries eg distributor markets as required
Work is performed with minimal immediate direction from a senior RA professional
May contribute to training or coaching of staff on key regulatory activities and updates under the direction of a
senior RA professional

Education & Experience

Capable of leading small project teams is beneficial
Must have the ability to work and negotiate with a HA
Ability to work on a number of projects with tight timelines
Excellent verbal and written English skills, organization skills and interpersonal communication skills required
5+ years of experience in RA or other relevant industry experience with BS/BA or 3+ years of experience in RA or
other relevant industry experience with advanced degree. Degree in a scientific field is preferred
Good knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical /
Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in
the local affiliate
Must be capable of developing and implementing regulatory initiatives and managing negotiations with the HA
Knowledge in quality assurance, promotional and non-promotional review as well as pharmacovigilance and market access
is advantageous
Experience in working and leading project teams
Good working knowledge regarding country/national and regional HAs (people, system, processes and requirements)

Ihr Kontakt

Lisa Bianculli, Recruitment Consultant, beantwortet Ihre Fragen gerne unter der Nummer +41 58 233 2102.

Bitte bewerben Sie sich direkt bei lisa.bianculli@springprofessional.ch

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