Regulatory Affairs CMC Specialist
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 CMC specialist supporting development projects and acting as a liaison between regulatory authorities and project teams on CMC, and potentially device constituents’ matters? And do you wish to make a difference in drug development projects as a proactive team player who can enable Zealand’s fast to patient strategy through cross-functional collaboration then you now have the chance to become a RA CMC specialist 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 Managers, RA CMC & Device Specialists, RA Associate and student assistants (a total of 10). You will be reporting to the Head of Regulatory Affairs.
- Support the CMC/Device project teams in developing and executing the optimal CMC and device regulatory strategies including risk assessments and input to project development plans
- Participate in development and review of CMC and Device regulatory documentation supporting clinical trial applications, annual reports, and marketing authorization applications
- Drive regulatory authority interactions on CMC and Device issues
- Be involved in the preparation for regulatory authority inspections, as well as relevant Q&As
- Provide regulatory input to due diligence exercises
- Work with regulatory consultants and experts on some of the above-mentioned tasks
- Liaise with our contract manufacturers and strategic partners
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:
- Acquired experience (>3 years) with drug development, preferably including regulatory CMC and device development or life cycle management, from Pharma, Biotech and/or Regulatory Agencies
- Experience with regulatory authority interactions
- A scientific and technical understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytics, and quality assurance)
- MSc and/or Ph.D. in Pharmaceutical Sciences or a similar degree in a relevant scientific field
- Collaborator with a relentless focus on creating results as a team
- 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.
- Apply -
Please apply no later than 2nd October 2022. Applications will be reviewed on a rolling basis.
No agencies or recruiters, please.
For further information, please contact Principal Regulatory CMC & Device Specialist Mette Clausen
at +45 5060 3758 or MClausen@zealandpharma.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. 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.
Principal Regulatory CMC & Device Specialist Mette Clausen at +45 5060 3758 or MClausen@zealandpharma.com