Director, Global Regulatory Affairs Operations Project Manager

At Genmab we are dedicated to building extranotordinary 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.

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.

Minimum Requirements/Qualifications

• Bachelors 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.

For US based candidates the proposed salary band for this position is as follows:

The actual salary offer will carefully consider a wide range of factors including your skills qualifications experience and location. Also certain positions are eligible for additional forms of compensation such as discretionary bonuses and long-term incentives.

When you join Genmab youre 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

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year if the employee performs well and if the business conditions do not change renewal for an indefinite term may be considered after the fixed-term employment contract.