Manager, Global Regulatory Affairs, Operations, Submissons, EU
Genmab
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
Regulatory Submission Manager is responsible for managing all submissions MAA/BLA/and IND applications. This will include working with functional teams of various disciplines to ensure compliant documents and adhering to timelines for document deliverables. This person needs to have strong communication skills, ability to lead, and understand submission requirements.
You will report to the Senior Director of Global Regulatory Affairs, Operations.
The position is based in Copenhagen, Denmark and is hybrid.
Responsibilities
Responsible for providing submission managing for MAA, BLA and INDs application.
Responsible for collaborating 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.
Requirements
BA/BS degree or equivalent, at least 5 years pharmaceutical industry experience, and prior Regulatory Operations experience required.
Knowledge of MAA/BLA/IND requirements and guidelines.
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 superior time management skills, and ability to work independently or in teams.
Strong attention to detail.
Ability to be proactive, enthusiastic and goal oriented
A great teammate with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (e.g. Scientists, Trial Managers, Data Managers, Clinicians, vendors labs) to support product development strategy
Strong communication skills - both oral and written
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 Job Applicant Privacy Notice (genmab.com).