Senior Regulatory Business Operations Lead

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Sobi Vollzeit
Job Title: Senior Regulatory Business Operations Lead

Job Summary

We are seeking a highly experienced Senior Regulatory Business Operations Lead to join our team at Sobi. As a key member of our Regulatory Affairs department, you will be responsible for leading and managing the Regulatory Business Operations team, ensuring the effective implementation and maintenance of regulatory systems, and providing strategic direction to the team.

Key Responsibilities

  • Lead and manage the Regulatory Business Operations team, including training, performance management, and coaching.
  • Make decisions on administrative and operational matters, ensuring the team effectively achieves its objectives.
  • Be responsible for regulatory systems, including Veeva RIMS, publishing tools, and related business processes.
  • Manage the GRA budget and keep the RDMA finance person updated on a regular basis.
  • Support and develop the implementation of Vendor Management processes and tools, and develop Quality Agreements (QAs) and service levels agreements.
  • Drive communication and training to ensure business operations team and outsourcing vendor adhere to the operating model and efficient execution.

Qualifications

  • University degree in Life Sciences required, with 10 years of industry experience, including 8 years in Regulatory Affairs and 5 years of formal people management.
  • Extensive experience in regulatory operations and project management.
  • Experience in leading and managing a team of subject matter experts.
  • First-hand experience working directly with service providers and demonstrated ability to manage and work with cross-functional teams in a complex environment.
  • Strong project and stakeholder management skills, excellent oral and written communication skills, and diplomacy to convey information and influence others.
  • Experience in change management, financial analysis, and negotiation.

Skills and Knowledge

  • Working knowledge of Veeva RIMS platform and regulatory systems.
  • Working knowledge of Veeva PromoMats.
  • Above-average proficiency with basic technology tools (e.g. MS-Office, etc.).
  • Demonstrate excellent communication skills (oral/written/listening) in English.

About Sobi

Sobi is a global company with over 1,700 employees in more than 30 countries. We are committed to the societies where we operate and are dedicated to making a positive impact in the lives of those affected by rare diseases. If you are seeking a career that taps into your talents and makes a difference, we invite you to join our team.

Why Join Us?

At Sobi, we refuse to accept the status quo. We have witnessed the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and those caring for them.

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