Be the new
Senior Regulatory Project Manager
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fast-growing, fully integrated Copenhagen-based biotechnology company with a highly attractive pipeline. With one product on the market, one candidate in registration and six candidates in the clinical pipeline, Zealand is a unique success story in Danish biotech. 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. In addition to the Søborg Headquarters, Zealand is also located in the United States in Boston (MA), Marlborough (MA), and New York (NY).
Join our growing Regulatory team of experienced regulatory professionals that focus on providing state-of-the-art regulatory strategic guidance and execution of operational tasks to our drug and drug-device projects. We do this in close collaboration with our in- and external stakeholders. While we aim for high performance in everything we do we emphasize to have fun while doing so and utilize the collective capabilities in the team and in the organization
Responsibilities include to:
The successful candidate will have most or all of the below qualifications:
- Be a project team member in specific drug and drug-device combination product projects
- Generate regulatory strategies and plans and execute them
- Drive regulatory agency interactions
- Provide regulatory input to early phase research projects and due diligence exercises.
- Contribute to updating of existing SOPs and developing new ones as needed.
- Work with assigned regulatory consultants and experts on some of the above mentioned tasks while maintaining overall responsibility, and ensure they deliver as agreed and to the expected standard
What we offer
Our employees are fundamental to our success, and we continue to be able 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.
- A MSc/PhD or equivalent within Life Sciences
- Several years of experience in a RA department in Pharma, Biotech and/or Regulatory Agencies
- Proven record of successful Regulatory Project Management preferably from drug-device development projects
- Regulatory agency interaction experience with key US and EU regulatory agencies
- Pharma value chain knowledge
- Strong scientific background with the ability to learn and adapt in a fast and flexible manner
- Strong interpersonal skills with the ability to work in teams and across cultures
- Ability to work independently and be able to drive and make decisions and execute them as needed
- Regulatory strategic mindset
- Excellent communication skills (verbal and written)
Our work environment is characterized by strong cross functional team-work, 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 warrant 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 our careers site and view our company video at:
Please apply no later than October 31, 2020.
For further information, please contact Trine B. Moulvad
at +45 5060 3715 or Tmoulvad@zealandpharma.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. 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.