id: NDk5OTM0MCA3

reference: 4999340

documentId: 4999340

connectionPointId: 7

lastModificationDate: 1559565014350

stillingsbetegnelse: Regulatory Drug-Device Combination Product Lead

jobbeskrivelse:

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 is looking for a Regulatory Drug-Device Combination Product Lead 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 our 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
• 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.

 

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, Pharmacovigilance & Medical Writing 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.

What we offer

Zealand’s employees are one of the company’s most important assets. We strive to attract, develop and retain the best talents, and to be a company where every employee can thrive.

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 salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities. To find out more about working at Zealand, visit our careers site and view our company video at: www.zealandpharma.com/zealand-as-a-work-place/ www.zealandpharma.com/video-about-zealand-new/

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C3322

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: ZEALAND PHARMA A/S

source: DK-STAR