Director, Global Regulatory Affairs Operations Project Manager

Genmab • Princeton, FL

14d

About The Position

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The Director, Global Regulatory Operations, Regulatory Project Manager Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products are established and maintained, and plans & directs the seamless execution of the GRT goals. Leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for late phase programs by providing effective Project Management leadership, oversight, direction and planning. Develops marketing application submission timeline and deliverables in collaboration with the GRL and cross-functional development team members. Develops and maintains regulatory milestone tracker across programs for department resourcing purposes.

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 as
• 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.

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.

Benefits

• When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness.
• Within the first year, regular full-time U.S. employees are eligible for:
• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

What This Job Offers

• Job Type: Full-time
• Career Level: Director