Head of Regulatory Business Operations

Head of Regulatory Business Operations

Sobi

Sweden

Job Description

The role leads and manages the Regulatory Business Operations team, is responsible for managing the GRA budget, Regulatory Systems and GRA outsourcing vendor.

Oversees the implementation and maintenance of the Veeva RIMS system (post Go-Live), Veeva PromoMats and provides strategic direction to the Regulatory Business Operations team and the projects they have oversight of.

Will be the primary contact for the outsourcing vendor GRA role and RDMA finance lead and ensure the successful implementation of a fit for purpose Vendor Management Tools and Processes and manage the budget.

Candidates located in Sweden are preferred.

Key Responsibilities/Scope of the Job

Including, but not limited to the following

• Provides leadership and line management to direct reports including training, performance management, professional development and coaching
• Makes decisions on administrative and operational matters and ensures the Regulatory Business Operations team effectively achieves its objectives
• Is responsible for the Regulatory systems including Veeva RIMs, publishing tools and related business processes
• Is responsible for the Veeva PromoMats Health Check and developing the strategic road map in collaboration with ISIT, Commercial and Medical
• Manages the GRA budget and keeps the RDMA finance person updated on a regular basis
• Supports and develops in collaboration with the Vendor Manager the implementation of the Vendor Management processes and tools, supports development and maintenance of Quality Agreements (QAs) and different service levels agreements (as applicable)
• Drives communication and training to ensure business operations team and outsourcing vendor adhere to the operating model and efficient execution
• Actively contributes to the development of a robust governance model and ensures that activities and documentation are agreed with relevant stakeholders are reviewed and updated on a regular basis
• Ensures vendor oversight with the alliance lead for GRA including but not limited to building, facilitating, and maintaining a long-lasting relationship between Sobi and the chosen GRA outsourcing vendor
• Actively contributes to developing or harmonising the governance structure, with the Vendor Alliance Manager
• Liaises with internal GRA teams, subject matter experts and stakeholders, the outsourcing vendor organisation, and procurement to support Service Agreement (SA) contract negotiations
• Develops strategic partnership Key Performance/Quality indicators (KPIs/KQIs) and assesses needs for process improvement
• Contributes to the development and maintenance of Regulatory Affairs working practices & procedures
• Additional duties may be assigned, as needed

Qualifications

Education/Learning Experience/Work Experience

• A University Degree in Life Sciences is required with 10 years of industry experience of which at least 8 years of experience within Regulatory Affairs in a business operations and vendor alliance management role and at least 5 years of formal people management
• Extensive experience of regulatory operations and project management
• Experience of leading and managing a team of subject matter experts
• First-hand experience of working directly with service providers, and demonstrated ability of managing and working with cross-functional teams in a complex, changing environment
• Strong project and stakeholder management skills
• Excellent oral and written communication skills and diplomacy to convey information and influence others with a strong customer focus
• Experience in change management, financial analysis, and negotiation
• Good use of MS office suite
• Fluent in English
• Global experience desirable

Skills/Knowledge/Languages

• Working knowledge of Veeva RIMS platform and knowledge of 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. Knowledge of any other languages would be an asset
• Proven to be able to be analytical, connect the dots and propose a strategy to address challenges and business needs

Personal Attributes

• Results driven and team-oriented attitude with the ability to influence outcomes
• Excellent organizational and time management skills to effectively manage multiple ongoing projects simultaneously
• Proven ability to innovate, especially with analysing & solving problems, with minimal supervision and exceptionally keen skills for attention to detail
• Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.
• Ability to travel occasionally (domestic and international)

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