Genmab is seeking a motivated individual to join a team committed to delivering quality submissions. A Senior Manager is responsible for activities related to regulatory publishing and submission management support to FDA, EMA, MHRA, SwissMedic and more. Seeks to contribute into innovation process while supporting GRA strategy and deliverables. 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 electronic submissions (eCTD and NeeS), including MAA, BLAs and INDs for Original Applications, DSURs, Supplements, and more.
Serve as the global submissions' expert, guiding teams on e-submission standards (eCTD, NeeS, etc.) and lifecycle management, while clearly communicating regional regulatory differences.
Perform QC and technical validation of electronic submissions to ensure compliance with internal standards and external criteria before delivery to the Regulatory Users for internal review/approval.
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 8 years pharmaceutical industry experience, and prior Regulatory Operations experience required.
Knowledge of IND, BLA, MAA,regarding CTD requirements and guidelines, for both eCTD and NeeS.
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
Nice to have submission management skills.
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
About Genmab
Benefits
Health insuranceRemote work options
Additional Information
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!
Genmab · Copenhagen, Denmark