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Regulatory Affairs Project Manager - Cross Functional

Vifor Pharma is experiencing unprecedented pipeline growth and realization in the field of rare disease, Nephrology and Cardio-renal therapies. A vacancy has arisen within the Regulatory Excellence Group to focus on cross functional project management of the various planned development and lifecycle management activities currently in progress at Vifor Pharma.

You will have a scientific background in the life sciences and some level of experience and knowledge of the CTD and other regulatory topics. Experience working in a fast paced environment and dealing with key priorities and timelines is essential for success. Partnering with regulatory, R&D and brand team stakeholders you will ensure that timelines and deadlines are adhered to to ensue the smooth submissions of key documentation to global and local health authorities.

Responsibilities
  • Support alignment and consistency between GRA and cross-functional business processes, systems, and planning processes in close collaboration with GRA Product Lead for assigned products
  • Maintain an overall Regulatory/CMRST planning process and calendar related to assigned products
  • Support an assigned GRA Therapeutic Area or Product Lead to ensure organizational alignment and consistency in approach, and execution across the department.
  • Proactively identify needs for process standardization, regulatory compliance direction and areas for improvement to promote global process effectiveness and continuous improvement.
  • Collaborate with key stakeholders (especially within CMRS functions) to ensure receipt of key deliverables to support project & submission timelines.
  • Provide expertise and support for data driven decision-making and metrics review; tracking progress and prioritizing according to plans.
  • Maintain structured information sharing processes (e.g. submission tracker), ensuring timely anticipation of adequate planning across Regulatory sub-functions
  • Keep informed about key trends related operational excellence approaches and initiatives in the pharmaceutical sector.
Minimum Requirements
  • Bachelor’s degree, preferably in pharmaceutical or health related field
  • Minimum 1 year of cross-functional strategic & operational planning experience
  • Experience managing cross-functional projects
  • Understanding of regulatory processes and related interfaces
  • Good understanding of pharmaceutical sector
  • Leadership experience from previous positions
  • Good computer skills (MS Office applications)
Preferred Requirements
  • 2-3 years of cross-functional strategic & operational planning experience
  • Experience with CTMS, RIM, ERP or Financial Reporting IT systems
  • Experience in managing large teams and multiple tasks
  • Familiarity with project management methodologies (e.g. PMBoK, PRINCE2) or certification in project management (i.e. CAPM, PMP, CPMP, MPM)
  • BA or MSc in Project / Process management or related field
  • Experience in anaemia, nephrology or specialty drug pharmaceutical environment

About Us

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.

Including:

  • 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.

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Deadline: 08-04-2024

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