Director, Global Regulatory Affairs Operations Project Manager
Genmab A/S, Princeton, New Jersey, us, 08543
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!
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
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.
For US based candidates, the proposed salary band for this position is as follows:
$195,520.00---$293,280.00
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, 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
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 you’re 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, Genmab’s 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 Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s 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.
#J-18808-Ljbffr
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!
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
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.
For US based candidates, the proposed salary band for this position is as follows:
$195,520.00---$293,280.00
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, 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
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 you’re 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, Genmab’s 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 Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s 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.
#J-18808-Ljbffr