Regulatory Drug-Device Combination Product Specialist - Gladsaxe
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Søborg
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.
Job profile
The successful candidate will:
The Candidate Profile
The successful candidate will have:
The department
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.
We offer
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.
Application
Please send your application and CV no later than 23 December 2019.
For further information, please contact Trine Moulvad, [email protected]
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.
Kilde: Jobnet.dk
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.
Job profile
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
The department
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.
We offer
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.
Application
Please send your application and CV no later than 23 December 2019.
For further information, please contact Trine Moulvad, [email protected]
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.
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 17.12.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktchef
- Søborg
- Mandag den 23. december 2019
Lignende jobs
-
Senior Procurement Manager
Are you motivated to work with procurement in large investment projects and contribute to ensuring we have sufficient production capacity to meet our patients’ future needs? Do you like responsibil..Få mere info- Produktchef
- Bagsværd
-
Product Owner – Control Tower T&I
We are a transport and logistics company providing the safe, reliable and efficient movement of people and goods - more than 12,000 colleagues, all committed to transforming our business into a gre..Få mere info- Produktchef
- København Ø
-
Product Owner – Vessel T&I
We are a transport and logistics company providing the safe, reliable and efficient movement of people and goods - more than 12,000 colleagues, all committed to transforming our business into a gre..Få mere info- Produktchef
- København Ø
-
Sourcing Project Lead
Are you experienced in facilitating sourcing projects and driving best practice? Do you have a strategic mindset and a passion for optimizing value, challenging ways of working, and making an impac..Få mere info- Produktchef
- Bagsværd
Statistik over udbudte jobs som produktchef i Søborg
Herunder ser du udviklingen i udbudte produktchef i Søborg over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal produktchef.
Se flere statistikker her:
Statistik over udbudte produktchef i Søborg over tid
| Dato | Alle jobs som produktchef |
|---|---|
| 12. november 2024 | 1 |
| 11. november 2024 | 1 |
| 10. november 2024 | 1 |
| 9. november 2024 | 1 |
| 8. november 2024 | 1 |
| 7. november 2024 | 1 |
| 6. november 2024 | 3 |
| 5. november 2024 | 3 |
| 4. november 2024 | 3 |
| 3. november 2024 | 3 |
| 2. november 2024 | 3 |
| 1. november 2024 | 3 |
| 31. oktober 2024 | 3 |
| 30. oktober 2024 | 3 |
| 29. oktober 2024 | 2 |
| 28. oktober 2024 | 2 |
| 27. oktober 2024 | 2 |
| 26. oktober 2024 | 2 |
| 25. oktober 2024 | 2 |
| 24. oktober 2024 | 2 |
| 23. oktober 2024 | 2 |
| 22. oktober 2024 | 2 |
| 21. oktober 2024 | 2 |
| 20. oktober 2024 | 4 |
| 19. oktober 2024 | 4 |
| 18. oktober 2024 | 4 |
| 17. oktober 2024 | 4 |
| 16. oktober 2024 | 2 |
| 15. oktober 2024 | 2 |
| 14. oktober 2024 | 2 |
| 13. oktober 2024 | 2 |