Be the new
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) aims to become a fully integrated biotechnology company leading in delivery of specialty medicines. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs.
Zealand is seeking an experienced Regulatory Associate to support our Regulatory Team of project leads and specialists with a variety of coordinating tasks. Our new Regulatory Associate will also have the responsibility for other independent operational activities related to our development projects and regulatory submissions.
The successful candidate will be an experienced Regulatory Associate/Coordinator preferably with late stage drug and drug-device development, and knowledge and skills within three main areas:
Clinical Trial Applications (CTAs)/Investigational New Drug Applications (INDs)
Driving submission planning and communication
Cross functional and external coordination (e.g. CROs, publisher, US agent) of documents and timelines
Input to cover letters and FDA forms for INDs
Prepare Q&A response documents using Zealand template
Ensuring efficient document/submission management including tracking, QC of submissions and e-archiving
Handling of regulatory documents in (e)TMF
Oversight and management of submission plans including ToC (eCTD structure) and adherence to timelines
Labeling (Package Insert, SmPC, packaging, Instructions for Use) coordination
QC of documentation and collaboration with vendors
Independent tasks and projects
Oversight and planning of tasks for our student assistants
Coordination and tracking of various submissions e.g. DSUR/Annual Reports
QMS support and process improvements (working closely with QA)
The successful candidate will have:
A bachelor in Pharmacy (e.g. Pharmakonom), nursing, laboratory technician or equivalent
Solid regulatory experience preferably within drug/drug-device development and submissions from a similar position
High-level of experience working in MS word and excel, Adobe, SharePoint, and electronic document management systems, as well as the ability to adapt to new systems and software as may be required
Excellent communication skills, with proficiency in oral and written English
Independent, self-driven and proactive
Open minded, flexible and collaborative
Good sense of humor
Diligent with the ability to maintain an overview while being able to focus on the details
You will be part of the Regulatory Affairs team in the Regulatory, Medical Writing & Pharmacovigilance department. We are a small team comprised of project leads and specialists, who support and challenge each other in order to find the best regulatory strategies for the Zealand projects. We are high-performing, ambitious, work independently and take responsibility for our own projects while focusing on functioning and delivering as a team. We aim to make a difference for the projects and for the development and approval of our products. We are busy but we make sure we have fun in our daily work.
What we offer
Zealand’s employees are one of the company’s most important assets. We strive to attract, develop and retain the best talents, and to be a company where every employee can thrive.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities.
To find out more about working at Zealand, visit our careers site and view our company video at:
Please send your resume/CV and cover letter no later than June 1, 2020.
For further information please contact VP and Head of Regulatory Affairs, Pharmacovigilance & Medical Writing, Trine B. Moulvad at email@example.com.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Zealand’s portfolio also includes two clinical license collaborations with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals.
Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Company's business and activities, please visit
or follow Zealand on LinkedIn or Twitter @ZealandPharma.