Be the new
Regulatory Drug-Device Combination Product Specialist
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 Pharma A/S is looking for a Regulatory drug-device combination product specialist to join the team responsible for executing our first NDA.
The successful candidate will:
- Take the lead on the drug-device and device parts of regulatory submissions
- Be an experienced combination product regulatory device expert with late stage drug-device development and NDA/BLA experience
- Be a team player who can enable our fast to patient strategy through close cross-functional liaison
- Provide regulatory strategic device guidance and operational tasks for assigned drug-device development projects incl developing regulatory device strategies including risk assessments, input to project development plans and writing/reviewing various device submission documents during the drug development and NDA phases.
- As part of the CMC/Device project teams find the best regulatory strategy and pathways for our device plans and know the potential shortcuts and pitfalls
- Drive Agency interactions on device issues
- Be involved in inspection Q&As ensuring proper response to Agencies
- Review device regulatory documents from a regulatory strategic perspective
- Provide regulatory input to due diligence exercises device changes
- Generate regulatory risk assessments for CMC and device changes
- Work with assigned regulatory consultants and experts on some of the above mentioned tasks
- Be our liaison to device manufacturers’ RA staff
The Candidate Profile
The successful candidate will have:
- Drug-device combination product regulatory expert knowledge
- Experience with the US and EU drug-device regulatory environment including FDA and EU Regulatory Agency interactions
- The wish to make a difference in our fast-paced late-stage development projects
You will be part of the Regulatory Affairs team in the Regulatory, Medical Writing & Pharmacovigilance department. We emphasize supporting and challenging each other in order to find and execute 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 project teams and for the development and approval of our products. We are busy but we make sure we have fun in our daily work. While we lay out the regulatory strategies internally, we collaborate with external regulatory contractors.
As an employee at Zealand you will be part of a stimulating and informal innovative working environment where you will interact with both colleagues and partners to deliver on our ambitious corporate goals.
We offer an exciting, interdisciplinary and challenging job at a workplace, which encourages continuous learning at work and sharing of best practices. We have an inclusive corporate culture where we believe in development of our employees and work-life balance. All employees at Zealand benefit from a competitive remuneration package including pension scheme and health insurance as well as lunch plan, physiotherapy, fitness room, and social clubs.
Would you like to know more about how it is to work at Zealand, we advise you to visit our career site at http://zealandpharma.com/careers/zealand-as-a-work-place.
Please send your application and CV no later than 23 December 2019.
For further information, please contact Trine Moulvad, 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 (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.