Senior Regulatory Publisher

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.

• Coordinates the submission of all types of annual reports and ensures timely submissions.

• Works directly with submission owners to address any publishing-related issues and ad-hoc requests.

• Utilizes various software tools and plugins to ensure documents and submissions meet all technical requirements for submission.

• Assists with development, documentation and maintenance of submission processes and training others as needed.

• Works in conjunction with team members for the creation of process documentation, work instructions and navigation sheets.

The job can, at times, be fast-paced, and the tasks are often associated with tight deadlines.

Your future team

Global Regulatory Publishing is a part of Regulatory Business Operations.

The position is based in Lundbeck’s headquarters in Valby (Copenhagen, Denmark), and the department consists of 7 highly experienced employees.

What you bring to the team

Our preferred candidate has the following personal and professional qualifications:

• 5 or more years of experience in Regulatory, Regulatory Operations or R&D Submission Support function within the pharmaceutical/biotech industry.

• Experience with eCTD publishing tools, electronic document management systems

• Proficient in working with IT systems and databases

• Service-minded, structured and detail-oriented

• Flexible and thrive in a fast-paced environment with frequent tight deadlines

• Analytical, goal-oriented and strong finisher

• Fluent in English

Our promise to you  

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn, Instagram (@h_lundbeck) or Twitter (@Lundbeck).

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Kishore Nasina, Head of GRP, +1 289-200-0184. 

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.