Genmab
Manager, Global Regulatory Affairs Operations, Publisher NJ
Genmab, Plainsboro, New Jersey, United States,
At 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 science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role
Genmab is seeking a motivated individual to join a team committed to delivering quality submissions. A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Seeks to contribute into innovation process while supporting GRA strategy and deliverables. Ensures adherence to established business standards within GRA and cross- functional stakeholders. Supports activities to implement new technology solutions in support of regulatory publishing business process.
Responsibilities:
Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including BLAs, INDs, MAAs for Original Applications, DSURs, Variations, PSUR, Supplements, and Amendments.Adherence to required submission timelines, health authority publishing specifications, and internal working practices.Liaise with functional source areas (clinical, nonclinical, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
Requirements:
BA/BS degree or equivalent, at least 6 years pharmaceutical industry experience, and prior Regulatory Operations experience required.Knowledge of IND, BLA, MAA, CTD requirements and guidelines, both paper and electronic.Knowledge of industry trends regarding electronic submissions.Technical knowledge of electronic publishing systems and software.Proficiency with MS-Office Suite and Adobe Acrobat application.Knowledge of health authority procedures/guidance's regarding electronic submissions.Knowledge of Electronic Document Management Systems.Ability to balance multiple tasks to meet priorities and timelines.Self-starter with superior time management skills, and ability to work independently or in teams.Strong attention to detail.Strong communication skills - both oral and written
For US based candidates, the proposed salary band for this position is as follows:
$95,625.00---$159,375.00The 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 bonuses.
About You
You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou 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 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.
The Role
Genmab is seeking a motivated individual to join a team committed to delivering quality submissions. A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Seeks to contribute into innovation process while supporting GRA strategy and deliverables. Ensures adherence to established business standards within GRA and cross- functional stakeholders. Supports activities to implement new technology solutions in support of regulatory publishing business process.
Responsibilities:
Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including BLAs, INDs, MAAs for Original Applications, DSURs, Variations, PSUR, Supplements, and Amendments.Adherence to required submission timelines, health authority publishing specifications, and internal working practices.Liaise with functional source areas (clinical, nonclinical, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
Requirements:
BA/BS degree or equivalent, at least 6 years pharmaceutical industry experience, and prior Regulatory Operations experience required.Knowledge of IND, BLA, MAA, CTD requirements and guidelines, both paper and electronic.Knowledge of industry trends regarding electronic submissions.Technical knowledge of electronic publishing systems and software.Proficiency with MS-Office Suite and Adobe Acrobat application.Knowledge of health authority procedures/guidance's regarding electronic submissions.Knowledge of Electronic Document Management Systems.Ability to balance multiple tasks to meet priorities and timelines.Self-starter with superior time management skills, and ability to work independently or in teams.Strong attention to detail.Strong communication skills - both oral and written
For US based candidates, the proposed salary band for this position is as follows:
$95,625.00---$159,375.00The 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 bonuses.
About You
You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou 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 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.