Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. The Director, Global Regulatory Affairs Operations Project Manager will partner with the Global Regulatory Lead to ensure project plans are established and executed, leading cross-functional teams to deliver regulatory submissions and maintain project milestones.
Responsibilities:
- Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings, to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for complex programs
- Proactively drive GRT and SWG project teams, establish appropriate level of urgency, and maintain focus on deliverables. Proactively lead teams to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution. Develop and maintain integrated regulatory project plans and integrated SWG plans
- Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management (and proposed solutions to support decision-making) for assigned programs. Collaborate with the GRL in presenting operational strategies and plan statuses to key stakeholders (e.g. Regulatory Leadership) as appropriate, through both scheduled and ad-hoc updates
- Drive decision making processes and escalating issues, as needed, ensuring proactive planning is taking place to enable delivery of all regulatory milestones for assigned programs
- Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to GRL and management
- Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross-functional team members and Global Regulatory Affairs colleagues. Identify and propose solutions for addressing potential systemic bottlenecks and constraints. Conduct lessons learned sessions for assigned programs; track project variances and identify root causes; detect, raise awareness and develop plans to address systemic concerns/issues
Requirements:
- Bachelor's degree required
- Ideal candidate has a minimum of 12 yrs related experience in the pharma/biotech industry (e.g. Regulatory Project Management), with 4 or more years in Global Regulatory Affairs
- Significant experience in global drug development regulations, regulatory submissions, compliance, business systems technology and process is required
- Experience with original and supplement/variations experience in multiple markets (e.g US, EU, JP and ROW)
- Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support is needed
- Demonstrates leadership, problem-solving ability, flexibility and teamwork
- Exercises good judgement in elevating and communicating actual or potential issues to line management
- Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging
- Demonstrates strong ability to collaboratively lead without line authority, interact and work effectively with other departments as well as external organizations
- Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment
- Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines
- Expertise with project management related software and tools (e.g. MS Project, OnePager, Office Timeline, SharePoint etc)
- Ability to travel 4-5 times per year