REGULATORY AFFAIRS MANAGER INFECTIOUS DISEASE/OTX - Geneva
Lieu: Switzerland - Meyrin/Geneva
Fonction: Regulatory Affairs
Compagnie: OM Pharma
We are currently looking for a Regulatory Affairs Manager for our OM Pharma site in Geneva to coordinate regulatory affairs activities for the products under responsibility; mainly for the region of Switzerland and EU. You will report directly to the Regulatory Affairs Team Lead Infectious Disease /OTX and your responsibilities will include, but are not be limited to:
- Manage successful submissions for new marketing authorisations, renewals, variations and line extensions for the following regions: EU, Switzerland and US
- Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities
- Responsibility for the designated regulatory projects with respective deadlines and forecasted budget, from regulatory assessment to strategy implementation
- Collaboration with the CMC, Regulatory International and Regulatory groups to ensure appropriate planning and timely execution of the regulatory activities
- Coordinate the responses to Q&A and ensure they are handled in a timely manner and in line with the approved product strategy
- Ensure compliance of dossiers with legislation and with the general requirements in EU and CH
- Coordinate the maintenance of up-to-date Modules 4, 5 and SmPC/PIL documentation according to international guidelines for products under responsibility
- Support regarding preparation and handling of Aggregate Safety Reports (PBRER, RMP…) according to internal procedures for products under responsibilities
- Represent regulatory affairs in relevant Project Teams (e.g. CMRST)
- Interact/entry contact point with Regulatory authorities, partners and consultants
- Interface with other departments on a national and international level
- Ensure tracking tools and regulatory databases are maintained up to date
We are looking for a customer- and service-oriented person who brings experience in working with a wide variety of stakeholders across diverse teams both internally and with external partner companies. Furthermore, your profile meets the following criteria:
- Scientific or Medical degree (pharmacy, chemistry or, biochemistry)
- Min. 7 years experience in Regulatory in Europe and Switzerland within a pharmaceutical company (experience in US would be an asset)
- Good knowledge and appropriate interpretation of guidelines, directives etc.
- Fluent in English, French (German would be an asset)
- Strategic thinking and acting, strong analytical and entrepreneurship skills
- Self-assertion, creative, solution-oriented work approach
- Accuracy, flexibility, open minded, team spirit, organised, autonomous
- Strong adaptability and excellent communication and negotiation skills
- Demonstrated ability to manage and lead projects successfully, interacting with senior stakeholders from different departments
You describe yourself as a solution oriented and flexible person who enjoys working in an intercultural environment. Your work is characterized by it’s accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines.
A propos de nous
Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.
Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.
Pour plus d’informations, veuillez consulter notre site: http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.
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