Senior Regulatory Publisher
4 weeks ago
Sr. Regulatory Publisher
(Global Regulatory Publishing, Regulatory Business Operations)
Lundbeck’s passion links to our purpose of restoring brain health so every person can be their best. We strive to make a real difference to patients. By developing innovative treatments, we improve the lives of people living with brain diseases. Your dedication is crucial. That is why you can expect us to be committed to your progress, so you can stay committed to ours.
Your new role – why is this a great opportunity?
We are looking for a Sr. Regulatory Publisher to compile and manage our Regulatory Submissions within Global Regulatory Publishing (GRP).
You will be a part of a global team that is distributed over three countries working on submissions to various health authorities with the opportunity to help establish various processes and projects.
GRP is responsible for providing support for initial application registration and post-approval activities of Lundbeck’s product portfolio by performing activities such as formatting, tracking, compiling, publishing, technical validation, submission and archival of regulatory dossiers to various Health Authorities. Other activities include maintaining access to Health Authority portals, point of contact for regulatory publishing-related queries, implementing new technology systems and processes for regulatory submissions.
Your job and key responsibilities
As a Sr. Regulatory Publisher, you will work independently to support activities related to the formatting, tracking, compiling, publishing, technical validation, submission and archival of regulatory dossiers to various Health Authorities, such as FDA, EMA, and ROW. The Regulatory Publisher will ensure compliance with regulatory requirements, guidelines, internal standards, and timelines. This role may also be assigned other operations-related responsibilities as needed.
Essential Functions:
Manages and prepares CTA/IND, NDA/MAA/BLA and DMF original and lifecycle regulatory submissions in eCTD format, including technical review of critical components for accuracy, and compliance with Health Authority requirements and internal standards.
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