We are looking for a professional to join our Regulatory Affairs Infrastructure team to work closely with internal and external stakeholders and IT to support our publishing tool in terms of updates/upgrades and to implement new interfaces to other regulatory relevant systems. The person will also support to design and develop regulatory processes to establish efficient new ways of working that will help to drive procedural and operational excellence. The role is based at our operational HQ in Glattbrugg, Zurich, and will be reporting directly to the Head of Regulatory Affairs Infrastructure.
In this role your tasks will include but not be limited to:
Support implementation activities, review and interpret release notes and new functionalities for the business
Support the implementation of the docuBridge interface with the eDMS system together with GRA business and IT stakeholders
Review existing, design and develop new processes and accommodate to leverage new system interfaces to support product expansion
Actively support the enhancement of electronic document management, regulatory submissions
Support annual and ad-hoc system upgrades/updates to meet health authority compliance and requirements
Further tasks according to directives from Line Manager
The ideal candidate brings the following skills and experience:
Degree in a scientific discipline
Minimum of 2-3 years’ experience in the pharmaceutical industry in a relevant area
Knowledge of Regulatory Affairs submission process in particular in eCTD publishing, eDMS and Regulatory Information Management tools
Experience of planning and compiling submissions for CH, EU, US and ROW
Experience in regulatory system implementation or equivalent
Excellent Microsoft Office skills
Publisher with experience of using docuBridge is preferred
Fluency in English, oral and written; German language skills are a plus
You have excellent communication skills and a solution oriented mind-set. You are capable of translating business requirements into IT requirements, able to identify risks during project implementations, and structure a large amount of information quickly. You have strong collaboration and teamwork skills, being able to work cross-functionally and with multiple stakeholders (internal and external). You set priorities according to needs, resolve issues appropriately and act as a role model for the Vifor Pharma values.
At Vifor Pharma, we use our skills, dedication, and entrepreneurial spirit to offer innovative solutions in iron deficiency, nephrology and cardio-renal therapies, so we can help patients around the world live better, healthier lives. This is why we come to work every day. Are you empowered to create a better world, and be part of life changing work? As a global pharmaceutical company, we offer the chance to be part of a worldwide team, where passion and commitment are met with opportunities for professional and personal development. Learn more at viforpharma.com/career.
What you can expect of us
As we work to support patients, we also take care for our employees’ professional and personal growth and well-being. We show appreciation and recognition through attractive benefits that will enhance your life, develop you, empower you to grow, and create your own career journey with us.
Open, safe and inclusive culture that fosters creativity and unleashes individual potential, whether in laboratories, manufacturing sites, in the field, or offices
Learning opportunities that enhances your skill set focused on business and personal effectiveness, leadership and management skills, and much more
Flexible workplace environment, home office opportunities, competitive vacation entitlement
Attractive ﬁnancial participation schemes, adapted regionally, that provide employees with additional security for every life situation, including: Pension plans, participation schemes, and savings plans
Join Vifor Pharma Talent Community
If you find that the role above is not suitable for your experience or career goals, but you want to keep in touch and learn more about Vifor Pharma and future career opportunities, join our Vifor Pharma Talent Community.