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.
Zealand Pharma A/S (Zealand) is looking for a CMC Submission Project Manager who is energized by working in close collaboration in teams on complex tasks with lots of fun and learnings.
You will be part of the very experienced CMC, Manufacturing and Submission team who is responsible for late-stage development and life cycle management activities.
You will be coordinating submission activities (mainly NDA/MAA submission in US/EU), while working in project teams together with other development functions. You will be working with several drug-device combination product submissions. Longer term there will be opportunity for leading project teams in drug development and life cycle management within CMC and Device.
- Coordination of CMC and Device regulatory submission preparations, including gap analysis, building the submission plan, ensuring kick-off and coordination of NDA writing activities and tracking of progress in collaboration with team members.
- Coordination CMC and device writing activities with CMC Technical Writer and several CMC scientists (API, DP, Device, Analytical and CMO Manufacturing)
- Reviewing and writing support to ensure content and storyline of the different sections.
- Ensuring Question and Answers process coordination and writing on CMC questions
- Longer term the position might develop into a CMC Project Management role for one or more projects, as tasks and responsibilities are gradually expanded
The successful candidate will have most or all of the below qualifications:
What we offer
- A Life Science degree within chemistry, biochemistry, pharmaceutical sciences, or another relevant field.
- At least 3-5 years’ experience from the Pharmaceutical Industry
- Experience with drug development processes and participating in cross-functional project teams
- Talent and passion for project management and experience with coordination of complex assignments
- Preferable experience with regulatory requirements for late stage/LCM CMC & device activities and content of regulatory submissions (NDA/BLA/MAA)
- Strong written and verbal communication skills in English
- Collaborative and structured nature
- The ability and engagement to “walk the extra mile”
- Interest in working in a dynamic environment and taking on new challenges
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.
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 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
Please apply no later than August 21, 2022.
For further information, please contact Britt Gren Sjøholm at +45 50603849 (best after 18-July) or Jakob Kristensen at +45 50603772
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.