Associate Director, Global Regulatory Affairs Project Lead
5 days ago
At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role & Department
As an Associate Director, Global Regulatory Affairs Project Lead, you will be a part of our Global Regulatory Affairs organization.
In this role, you will represent RA in the Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of the clinical trial submissions in EU/ROW. The chosen candidate may also be allocated as EU/ROW regulatory strategy lead to one or multiple compounds in early development and provide regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team to ensure an optimal EU/ROW regulatory strategy for the compound. This position will report to the Global Regulatory Strategy Team Lead.
Key responsibilities include:
- Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
- Represent EU/ROW in the Global Regulatory Team(s).
- Act as EU/ROW regulatory lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW strategy.
- Lead the preparation of strategic regulatory documents, e.g., Briefing Packages, ODDs, PIPs, etc.
- Plan, prepare and lead EMA or national Scientific Advice procedures, as relevant.
- Evaluate regulatory risks and recommend mitigation strategies to the cross-functional teams and management.
- Monitor and assess regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
- Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working.
Requirements:
- A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. Master's degree preferred.
- Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase.
- Experience in proactively planning and executing highly complex clinical submission strategies.
- A good understanding of drug development and EU regulatory procedures. Experience within oncology will be a plus.
- Prior experience leading health authority meetings with the EMA or other health authorities. Experience with PIPs will be a plus.
- Strong project management skills.
Moreover, you meet the following personal requirements:
- Strong organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
- Must have attention to detail and be able to solve problems with minimal supervision.
- Be able to work independently with an ability to drive projects to successful outcomes.
- Robust cross-functional teamwork skills and enjoy working in a global environment.
- Skills in building and maintaining internal and external collaborative relationships to achieve shared goals.
- Highly motivated and self-driven individual who enjoys being challenged.
- Able to prioritize your work in a fast-paced and changing environment.
- Goal-oriented and committed to contributing to the overall success of Genmab.
This role is located in Copenhagen, Denmark and is hybrid, which means on-site presence 60% of the time.
About You:
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving.
- You are a generous collaborator who can work in teams with diverse backgrounds.
- You are determined to do and be your best and take pride in enabling the best work of others on the team.
- You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion:
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
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 .
Location: Copenhagen - Carl Jacobsens Vej 30
#J-18808-Ljbffr-
Regulatory Affairs Project Director
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionWe are seeking an experienced and skilled professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will be responsible for managing the regulatory aspects of our clinical trials in EU/ROW, including preparing and submitting regulatory documents, leading EMA or national Scientific Advice...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeRole OverviewWe are seeking a highly skilled and experienced professional to join our Global Regulatory Affairs organization as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will represent RA in the Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of...
-
Regulatory Affairs Associate Director
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe're expanding our team and seeking a seasoned Regulatory Affairs Associate Director - Biologics to join our Regulatory Affairs CMC team. As a Team Lead, you will lead a sub-team while actively contributing to regulatory projects. Your experience in developing and executing CMC strategies, interacting with health authorities, and ensuring...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Director/Associate Director, Global Regulatory Affairs - CMC At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
-
Global Regulatory Affairs Leader
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleWe are seeking a highly experienced Senior Manager/Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs organization. As an integral part of our team, you will be responsible for ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW.In this role, you will represent RA in the Clinical...
-
Global Regulatory Strategy Lead
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThis is an exciting opportunity to join our team as an Associate Director, Global Regulatory Affairs Project Lead. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring the success of our clinical trials in EU/ROW.In this role, you will be responsible for providing regulatory expertise and...
-
Global Regulatory Affairs Project Lead
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to developing groundbreaking antibody products that transform the lives of patients suffering from cancer and other serious diseases. Our team is driven by a passion for innovation and a dedication to pushing the boundaries of what's possible.The Role & DepartmentWe're seeking an experienced Regulatory Affairs professional to join...
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma Full timeSenior Manager/Associate Director, External Programs, Global Medical Affairs Are you passionate about changing the lives of people living with rare diseases? Are you enthusiastic about operations? Do you have experience planning and executing Global Medical Affairs external programs or clinical trials within Clinical Operations? If so, now is your chance to...
-
Associate Director, EU/ROW Regulatory Lead
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at . Associate Director, EU/ROW Regulatory Lead page is loaded Associate Director, EU/ROW Regulatory Lead Apply locations Copenhagen time type Full time posted on ...
-
Regulatory Affairs Director
3 days ago
Copenhagen, Copenhagen, Denmark Pandora AS Full timeAbout the JobPandora A/S is seeking a highly motivated and experienced Regulatory Affairs Director to lead our global regulatory affairs function. As a key member of our team, you will be responsible for ensuring that we maintain the highest standards of regulatory compliance and integrity.Main ResponsibilitiesDevelop and implement effective regulatory...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
Regulatory Affairs Director
2 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe are seeking a skilled and experienced Regulatory Affairs Director to join our team at Genmab A/S. As a key member of our Regulatory Affairs CMC team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of...
-
Global Regulatory Affairs Project Lead
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking an experienced Global Regulatory Affairs Project Lead to join our team in Copenhagen, Denmark. In this role, you will be responsible for leading the development and execution of the EU/ROW regulatory strategy for assigned projects.Key ResponsibilitiesAct as EU/ROW regulatory lead and EMA contact person for assigned...
-
Regulatory Affairs Leader
7 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the JobWe are seeking a seasoned Regulatory Affairs professional to join our Global Regulatory Affairs team. As a Senior Director, you will be responsible for the development and implementation of EU/ROW regulatory strategies for Genmab's programs across all stages of development. You will work closely with cross-functional teams to ensure an optimal...
-
Director, EU/ROW Regulatory Affairs
3 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the TeamOur Global Regulatory Affairs team is responsible for ensuring that Genmab's programs meet regulatory requirements and are developed and implemented in accordance with EU and international regulations. We work closely with cross-functional teams to ensure that our programs are developed and implemented in a way that meets regulatory...
-
Regulatory Affairs Lead
3 days ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeJob SummaryThis role is an excellent opportunity for a seasoned Regulatory Affairs professional to lead regulatory projects both locally and globally. The ideal candidate will have a strong background in regulatory compliance, excellent communication skills, and the ability to work effectively in a fast-paced environment.The selected candidate will be...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout GenmabGenmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. We leverage translational research and data sciences to develop next-generation antibody technology platforms, including bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced...
-
Regulatory Affairs Manager
4 days ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeJob Description Summary LOCATION: Copenhagen, DenmarkROLE TYPE: Hybrid working (3 days per week in the office) As a member of the Regulatory Affairs (RA) team in Copenhagen, you will get the opportunity to work in a dynamic, agile team who has a common goal to bring our medicines to patients. We are looking for a Regulatory Affairs Manager or...
-
Global Medical Affairs Operations Director
3 days ago
Copenhagen, Copenhagen, Denmark Ascendis Pharma Full timeCompany OverviewA fast-growing biopharmaceutical company, Ascendis Pharma is dedicated to making a meaningful difference in patients' lives by developing new and potentially best-in-class therapies to address unmet medical needs. Our core values of patients, science, and passion drive our mission to apply our TransCon technology to build a leading, fully...
