Be the new
Regulatory Associate (option for part time)
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. 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 was founded in 1998 in Copenhagen, Denmark, and has presence in the U.S. as well
We are looking for a highly motivated and qualified Regulatory Associate with hands-on experience from managing regulatory submissions within a drug or drug/device development organization. You will join an exciting environment where highly engaged colleagues are committed to ensuring Zealand drug candidates are developed in the most optimal way to ensure minimum time to market. Regulatory Affairs is a fast-changing field where no two days are alike, and the employees in our department need a unique combination of scientific insight and the ability to navigate tight deadlines and many stakeholders. Our Regulatory Associate will work closely together with the remaining regulatory team and across Zealand projects to deliver on Zealand’s ambitious drug development portfolio. Likewise, the Regulatory Associate will be responsible for driving independent operational activities related to our development projects and regulatory submissions. You will be working in close collaboration with our other Regulatory Associate to ensure smooth planning, execution and continuous sparring.
The Regulatory Affairs department in Zealand is expanding and therefore we are looking for a new colleague to join our fantastic team. We are 12 highly engaged employees with a strong background in regulatory affairs and drug development and our roles span RA Project Leads, RA CMC & Device Specialists, an RA Associate and student assistants. You will be reporting to the Head of Regulatory Affairs. Our work culture in the team is defined by trust and openness, sparring, challenge and knowledge sharing and collaboration – and at any time there is always a colleague ready to help
The successful candidate will have most or all of the below qualifications; however, you are encouraged to apply even if you do not fulfil all criteria.
- Administrative responsible for driving the planning, coordination and execution of activities related to compiling, submission and approval of CTA/IND/NDA/MAAs in line with the regulatory strategy for Zealand projects
- Support the preparation of regulatory documentation for the CTA/IND/NDA/MAA as appropriate
- Coordinating and executing operational tasks including communication with relevant stakeholders regarding timely delivery of high-quality submission ready documents
- Ensure regulatory compliance and tracking according to relevant procedures and IT systems at Zealand including filing, updating and tracking of key data in the relevant systems
- Handling of regulatory documents in (e)TMF including oversight
- Handling regulatory submissions in EMA’s Clinical Trials Information System (CTIS)
- Engage with external publishing vendor
- Ensuring day-to-day adherence with ICH and FDA/EMA guidelines and regulations
- Support the Regulatory Affairs infrastructure by ensuring that the processes and systems are up-to-date and meet the business needs
- Solid experience from working in Regulatory Affairs handling submissions and approvals of CTA/IND/NDA/MAAs
- High-level of experience working in MS Word and Excel, Adobe, SharePoint, EDMS and (e)TMF as well as the ability to adapt to new systems and software as may be required.
- Experience with handling CTAs in CTIS will be an advantage.
- Experienced in working with process optimization and improvements
- Pharmaconomist, Medical Secretary, Bachelor’s in Pharmacy, Science, Nursing, Marketing or similar.
What we offer
Our employees are fundamental to our success, and we strive to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Zealand DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.
Our work environment is characterized by strong cross functional teamwork, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
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 compensation package which includes a base salary, pension, bonus, and an attractive employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit www.zealandpharma.com.
For this position we offer the possibility for part time work (minimum 30 hours per week).
Please apply no later than 30th November 2022. Applications will be reviewed on a rolling basis.
No agencies or recruiters, please.
For further information, please contact Senior Regulatory Associate Charlotte Samsø at +45 5060 3861 or firstname.lastname@example.org.
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. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.
- Collaborator with a relentless focus on creating results as a team
- Pay attention to details while maintaining the big picture and clear focus
- Structured, organized, and a proactive problem-solver with a can-do attitude
- Work independently, but you are also the team player who helps and cares about your colleagues and contributes to the good atmosphere in the department
- Strong communication skills in both written and spoken English and preferably also in Danish
- “Zealander” who thrives in a strong culture characterized by the Zealand DNA as defined below