Denmark Job Openings
Genmab
Submission Manager, Global Regulatory Affairs Operations
Copenhagen
FULL TIME
September 12, 2024
- Responsible for providing submission managing for CTA applications.
- Responsible for communicating with project managers, regulatory leaders, and/or content authors to discuss planned submission preparation. Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
- Liaise with functional source areas (Clinical, Nonclinical, CMC) to ensure documents are compliant and submission ready. Work with regulatory document authors to achieve resolution and ensure that documents align with regulatory and company guidance/template specifications.
- Identifies regulatory risks and emerging issues and proactively develops mitigations and solutions.
- Ensures that all regulatory content and information is appropriately tracked, archived, searchable, and accessible via Document Management System.
- Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
- Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
- BA/BS degree or equivalent, and at least 6 years pharmaceutical industry experience.
- Strong knowledge of CTA requirements and guidelines. Knowledge of IND and BLA's is a plus, but not a requirement.
- Proficiency with MS-Office Suite and Adobe Acrobat application.
- Knowledge of health authority procedures/guidance's regarding submissions.
- Knowledge of Electronic Document Management Systems. (Veeva)
- Ability to balance multiple tasks to meet priorities and timelines.
- Self-starter with outstanding time management skills, and ability to work independently or in teams.
- Strong attention to detail.
- 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
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