Senior Manager - Regulatory Clinical Support

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Regulatory Affairs

Votre profil

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. A position has arisen within the Global Regulatory Affairs function in our Clinical Support Team for a Senior Manager  to focus on clinical support of development compounds across the whole Vifor Pharma portfolio. 

You will support regulatory product strategy development teams to evaluate and execute clinical regulatory strategies and protocols to achieve business objectives, approvals and optimal labels as well and maintain current regulatory and clinical intelligence with respect to the changing landscape of clinical development strategies.

We are looking for a seasoned individual from CRO or sponsor side who has demonstrable expertise of the above and who has extensive stakeholder management capabilities to drive through change and new initiatives as well as meet the agreed business objectives. On offer is the opportunity to join a business which has a robust, innovative and growing pipeline of drug candidates and a significant global expansion plan and who is focused on improving the health and wellbeing of our patient populations.

Regulatory/Clinical strategies and study protocols 

Support Head of GRA clinical Support and RA Therapeutic Area Leads and Team Leads
  • In developing and evaluating global clinical/regulatory strategies and study protocols to ensure effective achievement of regulatory/business objectives, approvals, and optimal labels.
  • With all means of regulatory intelligence to keep informed about key regulatory trends related to clinical development and clinical requirements supporting new product approvals.
  • By ensuring regulatory compliance with relevant regulations, guidance as they apply to Vifor Pharma clinical programs with assigned responsibility

Clinical Support activities:
  • According to assigned responsibility by Head of Clinical Support and in alignment with goals of the GPTs and GRA TA leads, participation in and active contribution to clinical study teams and related meetings to Vifor Pharma clinical programs by acting as a driver towards timely resolution of the following activities:
  • Development and design of clinical protocols
  • Oversee RA tasks of CROs, review CTA packages and ensure their submission, coordinate answers to HA queries, etc
  • Handling and submission of regulatory safety documents (IB, DSUR, etc) with the CRO in charge according to internal procedures and HA/EC requirements
  • Assess need for and content of amendment to clinical protocols
  • Regulatory Excellence, Data Transparency and Regulatory Intelligence:
  • According to assigned responsibility by Head of Clinical Support:
  • Support team efforts to elevate Regulatory Intelligence capabilities (electronic, web-based, IA-based system)
  • In collaboration with Head of Clinical Support: development of Vifor cross-functional R&D clinical procedures, and for organizational structure and systems related regulatory elements of clinical research.
  • Develop and implement appropriate clinical data transparency strategies for VIFOR clinical studies and products
Tasks 
  • Participates and contributes as a member of the CSTs by giving regulatory inputs for the assigned clinical studies and therapeutic area
  • Ensures execution of regulatory plans through personal contribution and the collaboration with other Vifor functions
  • Builds up and maintains a regulatory network, including support for the regulatory functions on the company’s sites and affiliates
  • Establishes and maintains constructive working relationship with key regulatory bodies to ensure alignment of Vifor Pharma development plan with the developing regulatory environment
  • Keeps informed about key regulatory trends; provides input from a regulatory perspective to Vifor Pharma development plans and projects
  • Proactively addresses industry trends and opportunities and communicates to appropriate management functions
  • Works effectively in cross-functional teams & provides regulatory support to development projects as required
Qualifications

Minimum Requirements
  • University degree, preferably in pharmaceutical or health related field
  • 10-12 years of experience in international regulatory affairs in the pharmaceutical industry (prescription drugs)
  • Demonstrated experience managing dossiers through FDA including study design, data review, approval strategies and labelling negotiations
  • Solid track record of delivery as shown by approvals/authorizations of substantial dossiers
  • Solid knowledge of the global regulatory environment and GXP regulations
  • Continuous training on relevant regulatory topics and guidelines
  • Flexible and result orientated; detail conscious and precise in adopting relevant standards
  • Computer skills
  • 5-10 % travel commitment

Other Preferred Requirements
  • Experience in anaemia, nephrology or specialty drug prescription environment

Languages:
  • Professional in English (oral and in writing)
  • Proficiency in German or additional languages an advantage

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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