Senior Regulatory Affairs Manager - Global Development focus

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Regulatory Affairs

Compagnie: Vifor Pharma

Medha Khanna

Senior Talent Acquisition Manager

Conditions pour les agences de placement

Votre profil

Regulatory Senior Manager – Global Regulatory Development 

Vifor Pharma is experiencing rapid pipeline growth and optimization in the field of Nephrology Rare disease and cardio renal medicine. Through our own R&D and global alliances the vision set forth by leadership will be transformational and position Vifor Pharma at the cutting edge of these therapeutic fields. 

As such growth within the regulatory group is planned and the recruitment of a Senior Manager Regulatory Affairs is needed to assist the global director with regulatory development programmes for novel molecules within the assigned therapy areas. 

You will have a strong background in regulatory affairs, particularly within pre approval of drugs in the EU or Global environment (EMA or FDA). Essential to this role is true regulatory strategy activities focused on lead up to regulatory filings 

Responsibilities 
  • Reporting to GRA Head of Development Programs, the Sr Manager will lead day to day regulatory activities of assigned projects:  
  • Active participation in development projects (Phase II, Phase III, registration, launch) to ultimately deliver a label reflecting the Target Product Profile (TPP)
  • Working closely with cross-functional teams to develop and implement global regulatory strategies
  • Leading the Regulatory Affairs Functional Team (RAFT) 
  • Acting as point of contact internally and externally for major topics related to Health Authority interactions for assigned projects
  • Coordinate support from external consultants and vendors as required to reach business objectives for assigned projects
  • Manage timelines, resources and budget to achieve stated objectives
  • Foster Vifor reputation with regulators as being science-based, reliable, and trustworthy by advocating for sound regulatory policies
  • Contribute to the development and implementation of processes and procedures relevant to the operations of the regulatory function and its interactions with internal stakeholders.
  • Act as deputy to Head of RA Development Programs for specified topics

Key Tasks
  • Provide strategic regulatory leadership on assigned projects
  • Provide strategic guidance on regulatory incentives which may be applicable to assigned programs and proactively communicate and plan for data generation to qualify for these incentives
  • Author and/or review global regulatory strategies & submissions, ensure these are adequately implemented and regularly updated in line with the needs of the respective program
  • Coordinate and plan Health Authority meetings and interactions
  • May represent the Global Regulatory Affairs (GRA) function at key global health authority meetings and with external stakeholders
  • Ensure coordination between parallel development tracks for multiple indications within the program
  • Lead GRA processes, in collaboration with respective sub functions, for relevant projects with timely strategic input in support of coordinated registration activities in EU, US, CH, AU, CN & JP
  • Monitor, analyze, and anticipate changes in the regulatory environment, including their impact to the development programs, clinical trial designs and endpoints or submission targets; implement necessary adjustments to strategies or content
  • Provide support and act as deputy of Head of RA Development Programs:
  • Take on specific strategic and organizational responsibilities
  • Functional representative to designated governance committees as assigned (e.g. CMRST, GBT, GCT)

Minimum Requirements
  • M.Sc. or Ph.D in life sciences
  • At least 10 years’ experience in Pharmaceutical Industry, thereof 5 years’ experience in Regulatory Affairs (with special emphasis on strategy and new product development)
  • Extensive knowledge and experience with regulatory procedures and legislation for drug development (Phase II, Phase III) and paediatric investigational plans
  • Extensive experience of authoring and/or reviewing of scientific briefing books and materials for submission to regulatory authorities 

Additional Qualifications
  • Extensive knowledge and experience with product registration in the EU and US, including specifically programs for rare diseases or other incentive programs to support early access of innovative medicinal products 
  • Experience in leading a cross-functional team or a regulatory group (with or without line management responsibilities) is a strong asset

A propos de nous

Chez Vifor Pharma, nous utilisons nos compétences, notre dévouement et notre d’esprit entrepreneurial afin d’offrir des solutions innovantes dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux et d’aider les patients du monde entier à mener une vie meilleure et plus saine. C’est la raison qui nous motive à nous rendre au travail chaque jour.
Vous sentez-vous à même de participer à la création d’un monde meilleur en effectuant un travail qui aura un impact ? En tant qu’entreprise pharmaceutique d’envergure mondiale, nous vous offrons l’opportunité de faire partie d’une équipe internationale dont la passion et l’engagement sont récompensés par des opportunités de développement professionnel et personnel. Pour en savoir plus: viforpharma.com/career.

Ce que nous offrons

Nous œuvrons certes dans le but de soutenir les patients, mais nous faisons également en sorte que nos collaborateurs puissent s’épanouir sur le plan professionnel et personnel et veillons à leur bien-être. Nous témoignons notre gratitude et notre reconnaissance par le biais de bénéfices attractifs qui sauront améliorer votre qualité de vie, vous permettront de vous développer, de vous épanouir et de bâtir votre carrière chez nous.

Ces bénéfices comprennent:

  • Une culture d’entreprise ouverte et inclusive encourageant la créativité et permettant d’exprimer son potentiel individuel, en sécurité, que cela soit dans les laboratoires, sur les sites de production, sur le terrain ou dans les bureaux;
  • Des opportunités d’apprentissage qui vous permettront d’étendre l’ensemble de vos compétences en vous concentrant sur l’efficacité de l’entreprise et votre développement personnel, les compétences liées au leadership et au management, et bien plus encore;
  • Un environnement de travail flexible, la possibilité de travailler à domicile et une politique avantageuse concernant les vacances;
  • Des plans attractifs de participation financière, adaptés selon la région, qui offrent une sécurité supplémentaire aux collaborateurs à chaque étape de leur vie, incluant des régimes de retraite, des plans de participation et des plans d’épargne.

Rejoignez la communauté de talents Vifor Pharma

Si le rôle décrit ci-dessus ne semble pas correspondre à votre expérience ou à vos objectifs de carrière mais que vous souhaitez tout de même rester en contact et en apprendre davantage sur Vifor Pharma et vos futures opportunités professionnelles, rejoignez notre communauté de talents Vifor Pharma.

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Conditions pour les agences de placement