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Project Lead, Regulatory Affairs

Project Lead, Regulatory Affairs
november 4, 2022 Hanne Beirholm
Zealand pharma job jobs arbejde stilling

Do you want to support development projects,and act as a liaison between regulatory authorities and project teams on strategic development matters ?

in a biotech company focused on the discovery, design and development of innovative peptide-based medicines

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.

Regulatory Affairs (RA) is a multi-disciplinary department where you work with stakeholders across the whole organization. As a strategic partner, RA plays an important role in ensuring Zealand drug candidates are developed in the most optimal way to ensure minimum time to market. RA professionals are involved through all phases of product development and life cycle management. Are you motivated by working as a proactive RA Project Lead supporting development projects and acting as a liaison between regulatory authorities and project teams on strategic development matters? And do you wish to make a difference in drug development projects as a proactive team player who can provide and drive state-of-the-art regulatory strategic guidance and enable Zealand’s fast to patient strategy through cross-functional collaboration then you now have the chance to become a RA Project Lead for one or more Zealand projects.

The RA department in Zealand is expanding and we are therefore looking for a new colleague to join our fantastic team. The team consists of RA Project Leads, RA CMC & Device Specialists, an RA Associate and student assistants. You will be reporting to the Head of Regulatory Affairs.

Job Profile

Responsibilities:

  • Lead project teams in relation to regulatory tasks (spanning early and late phase projects and submission through approval of New Drug Applications/Marketing Authorization Applications)
  • Be a project team member in specific drug development projects
  • Generate regulatory strategies and plans and execute on them
  • Drive regulatory agency interactions
  • Provide regulatory input to projects and to due diligence exercises
  • Share learnings, regulatory insights and spar with RA colleagues
  • Work with assigned regulatory consultants and experts on tasks while maintaining overall responsibility, and ensure they deliver as agreed and to the expected standard, when external consultants are involved in projects

Candidate Profile

The successful candidate will have most or all the below qualifications; however, you are encouraged to apply even if you do not fulfil all criteria.

Experience

  • Experience from an RA department from Pharma, Biotech and/or Regulatory Agencies
  • Experience with regulatory authority interactions, ideally US and EU agencies
  • Experience with Regulatory Project Management (ideally as RA lead) preferably from drug-device development projects or life cycle management
  • Pharma value chain understanding

Education

  • MSc and/or Ph.D. in Pharmaceutical Sciences or a similar degree in a relevant scientific field

Personal qualifications

  • Collaborator with a relentless focus on creating results as a team
  • Strategic mindset
  • Ability to work independently and be able to drive and make decisions and execute them as needed
  • Values interpersonal relationships and contributes to a positive work environment
  • Strong communication skills in both written and spoken English
  • “Zealander” who thrives in a strong culture characterized by the Zealand DNA as defined below

What we offer

Our employees are fundamental to our success, and we strive 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.

Zealand DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.

Our work environment is characterized by strong cross functional teamwork, 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.

Application

For further information, please contact Beirholm Search, Hanne Beirholm tel. 29440080 for further information.

Applications will be reviewed on a rolling basis.

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.





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