Lieu: Switzerland - Glattbrugg/Zurich
Fonction: Regulatory Affairs
Vifor Pharma a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, we are experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. At this time we are looking to appoint into the Regulatory Affairs team a Global Regulatory Product Strategists to be aligned with a recently approved product and provide ongoing support for follow on indications and lifecycle management. This will be a crucial role with high impact and visibility for a launch product which will bring a life-improving treatment regimen to our patients.
Lead the Global RA activities for assigned product(s) by:
- Active participation in assigned 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
- Leadership of the Regulatory Affairs Functional Team (RAFT)
- Ensuring strategic submissions on plan
- Working closely with external development partners to navigate the regulatory landscape internally and externally
- Acting as point of contact internally and externally for major topics related to Health Authority interactions for assigned product(s)
- Coordinating support from external consultants and vendors as required to reach business objectives for assigned projects
- Managing timelines, resources and budget to achieve stated objectives
- Ensure that the interactions between Regulatory and other departments are managed optimally to enable achievement of program targets
- 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 GRA Product Strategy - Therapeutic Area for specified topics
Key Measures of Success
- Effective management and leadership of the Regulatory Affairs components related to assigned product(s)
- Optimal regulatory support for Global Brand Team (GBT) and Executive Committee (EC) objectives, and to other relevant stakeholders by the team
- Effectiveness of collaboration of the team with other relevant functions and teams within the company, affiliates and development partners to achieve project deliverables
- Quality of planning, information and inputs provided by the teams to the stakeholders and product teams
- Successful regulatory outcomes according to plan, successful remediation of identified risks
- Success of the teams in producing on-time and accurate deliverables (e.g. strategic plans, submissions, evaluations, due diligence)
- Performance of team members on assigned project teams
- Development of team member’s knowledge and capabilities
External reputation of Vifor by Health Authority regulators as a development organisation, and in particular as an innovator in the treatment of kidney disease
Delineate cost-effective resource budget, and manage costs accordingly
Provide strategic Regulatory leadership for the assigned product(s):
- Guidance to internal global brand teams (GBTs), product and project teams on strategy, benefit/risk (including CMRSTs), data requirements and label development as well as key life cycle development activities.
- Strategy input into integrated development plans enabling optimal product launch and market access.
- Ensure regulatory strategies are developed to deliver Target Product Profile (TPP) label, including parallel development tracks for multiple indications within the programs.
- Leadership for GRA processes for relevant projects with timely strategic input in support of coordinated registration activities globally.
- Lead Health Authority Meetings for assigned product(s)
- Author, review and approve global regulatory strategies & submissions, as well as company contributions to policy consultation or legal proceedings related to assigned product(s).
- Monitor, analyze, and anticipate changes in the regulatory environment, including their impact to assigned product(s), submission targets or clinical trial designs; implement necessary adjustments to strategies or content.
- Leverage regulatory health authorities (e.g. FDA, EMA, key national competent authorities), industry trade associations’, and other relevant organizations’ insights to advance Vifor’s position related to regulatory and safety policy
- Take on specific strategic and organizational responsibilities in consultation with of Head of GRA Product Strategy - Therapeutic Area
- BS, BA in a relevant scientific discipline, or BSN/BSc in Nursing. However MA/MS or PhD in life sciences or chemical engineering, or PharmD preferred
- At least 10 years’ experience in Pharmaceutical Industry
- Direct experience interacting with national Health Authorities
- Excellent knowledge of and prior experience with developing and launching products globally, with particular emphasis on US and/or EU
- Fundamental understanding of the contents of product dossiers and critical attributes of medicinal products for registration
- Excellent verbal and written communication skills in English.
- Experience in leading a regulatory or a cross-functional team
- Prior involvement in registrations outside of the US and EU (for example Japan, China)
- Well known in regulatory community with good Health Authority contacts
- Understanding and speaking German and/or French is a strong asset
A propos de nous
Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.
Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
Pour de plus amples informations, veuillez consulter www.viforpharma.com/career
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