Swedish Orphan Biovitrum is looking for a Regulatory Policy and Intelligence Lead to join its growth journey. We have several development projects in our portfolio as well as marketed products to be supported. In parallel, we are expanding into new markets with our products.
The Global Regulatory Policy and Intelligence team advances important policy issues, aligned with Sobi’s goals and priorities by engaging externally with regulators, industry trade associations and patient advocates, along with internal subject matter experts across Sobi. In this role you will support the development, articulation, and implementation of Sobi’s position on regulatory policies that impact Sobi’s business. The role is reporting to the Head of Global Regulatory Policy, Intelligence and Advertising and Promotion.
The Operations Manager provides high-level organizational and operational support to ensure effective coordination of daily business activities. This role operates at a significant level of responsibility, autonomy, and ownership of departmental operations.
The purpose of the role is to serve as the central point of coordination for processes, communications, compliance routines, and documentation, ensuring smooth and consistent operational execution. The Operations Manager enables the leadership team and their direct reports to focus on strategic priorities by managing operational complexity and creating structure, clarity, and efficiency.
Key Responsibilities
Operational Coordination & Workflow Management
- Independently manage the day-to-day operations of GVA, ensuring tasks, priorities, and timelines are aligned and executed. This includes tasks such as contracting, Veeva reviews and approvals, Docu-sign submissions, SmartSheet budget/project trackers, reimbursement trackers, and dashboards.
- Proactively identify bottlenecks and propose streamlined procedures that improve organizational efficiency within GVA.
Administrative Excellence
- Provide high-quality support during the planning and execution of key GVA events such as GVA F2F meetings, Patient Access Leaders meetings (PALM), Patient Access Network meetings (PAN), and strategic payer and contracting trainings.
- Maintain oversight of document repositories, ensuring version control, compliance with SOPs (e.g., promo and non-promo materials), and easy navigability for the team.
Cross-Functional Liaison
- Serve as the first point of contact for internal stakeholders (Finance, Legal, Procurement, Compliance, etc.).
- Support onboarding of new hires, liaising with HR and functional leads to ensure a consistent, high-quality onboarding experience. Take responsibility for keeping the GVA onboarding program up to date and ensuring its effective deployment.
Project & Process Support
- Support GVA projects by coordinating compliance tasks, timelines, and documentation.
- Report to GVA LT on project trackers highlighting priorities, risks, delays, or resource needs.
Financial & Vendor Support
- Manage POs, vendor onboarding steps, and invoice tracking.
- Ensure alignment with procurement rules and escalate issues where needed.
- Support budget monitoring (e.g., tracking spend vs. plan, maintaining GVA trackers).
Key Interactions
- Internal: Leadership Team; cross-functional partners (Finance, Procurement, Legal and Compliance); country affiliates (where relevant).
- External: Vendors, agencies, and consultants; event coordinators or external partners (as applicable).
Education
- Bachelor's degree preferred (e.g., Business Administration, Communication, Operations, or similar).
- Equivalent experience considered.
Experience
- 3+ years in coordination, operations, or project support roles.
- Experience in a multinational or matrixed environment preferred.
- Experience in pharmaceutical/healthcare/regulated environments is an advantage.
Skills
- Strong organizational, planning, and coordination skills.
- Ability to manage multiple tasks and priorities with minimal supervision.
- Excellent communication and interpersonal skills.
- Strong proficiency in Microsoft Office and collaboration platforms (Teams, SharePoint, Outlook).
- Ability to draft and structure documents, presentations, and reports professionally.
Personal Attributes
- Proactive, resourceful, and solutions-oriented.
- Dependable, detail-oriented, and structured.
- Able to handle sensitive information with discretion.
- Comfortable navigating a dynamic, fast-paced environment.
Skills Required
- 3+ years in coordination, operations, or project support roles
- Proficiency with Microsoft Office and collaboration platforms (Teams, SharePoint, Outlook)
- Experience managing contracting, vendor onboarding, POs, and invoice tracking
- Ability to manage multiple tasks and priorities with minimal supervision
- Strong organizational, planning, and coordination skills
- Excellent communication and interpersonal skills
- Ability to draft and structure documents, presentations, and reports professionally
- Comfortable handling sensitive information with discretion
- Bachelor's degree (Business Administration, Communication, Operations) or equivalent experience
- Experience in a multinational or matrixed environment
- Experience in pharmaceutical/healthcare/regulated environments
- Familiarity with Veeva, DocuSign, SmartSheet, and dashboard/reporting tools
What We Do
Sobi is an international biopharmaceutical company dedicated to transforming the lives of people living with rare diseases. Focused on haematology, immunology, and specialty care, the company develops and delivers innovative therapies and breakthrough medicines to patients globally. They aim to improve the lives of those with rare and debilitating diseases through scientific innovation and extensive patient support networks.
