Regulatory Affairs Data Governance and Quality Capability Lead

Key Responsibilities

• Lead a team to ensure alignment with organizational goals and business priorities related to Data Governance and Quality
• Serve as Data Governance and Quality Capability Lead for RA and as the point of contact for GDD Data team
• Lead RA cross-functional teams to develop data roadmap, in alignment with cross-domain Data Governance boards
• Accountable to create and implement data management and quality strategy
• Expert contributor to influence draft guidance on data standards / specifications / implementation from Health Authorities and Trade Organizations. Prepare interpretative analyses about impact on internal data and digital processes.
• Collaborate with Development Data Management and DDIT partners to develop and implement RA Data Governance structures (boards) and policies, ensuring involvement of Business Process Owners (BPOs) and business SMEs.
• Oversee vendors at the Capability level, in collaboration with IT and the External Partnerships Teams
• Manage Data Governance and metrics reporting on data operating model throughout the DQM lifecycle
• Responsible for configuration, decision making and outcome, impacting the capability, with involvement of relevant Business Process Owner(s), business SMEs and stakeholders

Qualification & Requirements

Essential Requirements

• Bachelor’s degree, master’s; Advanced degree in life science, pharmaceutical, technology or data science preferred
• 8+ years of relevant industry experience
• Strong understanding and direct relevant experience with the Data Strategy and Management landscape of pharmaceutical regulatory affairs and Regulatory Information Management
• Strong network and exposure to the external environment and ability to represent company and influence in Trade organizations (e.g., EFPIA, PhRMA), International Organizations (ISO), and collaboration with regulators (e.g. ICH, EMA SPOR), or consortiums
• Advanced knowledge of worldwide evolving external data standards as well as drug registration and approval processes and related document format requirements and in-depth knowledge of good Regulatory compliance and intelligence practices, policies, procedures
• Strong understanding of regulatory requirements and structured data submissions standards and initiatives
• Excellent business writing, communication and effective presentation skills.
• Extensive experience leading meetings, driving change and cross-functional teams

Desirable Requirements

• Strong strategic problem-solving skills and ability to innovate, analyze and navigate un-charted territory without clear precedent, ability to troubleshoot effectively, accurately and independently.
• Strong negotiation skills

Benefits

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.