Loading...

@

  • Regulatory Affairs Clinical Specialist Søborg
  • Zealand Pharma in Søborg, , Denmark
  • jobs
  • 1 month ago

jobs description

We are expanding our Regulatory Affairs team due to many activities in our exciting clinical development projects and are seeking two new colleagues to our Regulatory Affairs function.

As a Regulatory Affairs Clinical Specialist, you will play a critical role in providing regulatory input and direction throughout the clinical development process. You will collaborate closely with cross-functional teams to navigate the complex regulatory landscapes and contribute to the successful execution of the regulatory strategies within clinical development. Your expertise will be instrumental in maintaining adherence to regulatory standards while facilitating the advancement of innovative medicinal products making a difference to patients.

Key Responsibilities:

As a Regulatory Affairs Clinical Specialist, you will work closely together with the Global Regulatory Project Director/Project Manager and be part of cross-functional sub teams.

Your key responsibilities will be to contribute with... regulatory expertise to global strategies and execution within your assigned project(s). You will be the regulatory responsible in the clinical trial teams and provide regulatory guidance and support for the planning, execution, and reporting of clinical trials worldwide, including protocol development, preparing clinical trial applications/Investigational New Drug application (IND), study conduct, and data analysis.

For our late-stage projects you will participate in the development of regulatory documentation for new Marketing Authorisation Applications (MAA) in EU/New Drug Application (NDA) in the US. You will support the submission of MAAs/NDAs including strategies for Q&A with health authorities ensuring high quality approvals.

You will work with engaged and experienced regulatory colleagues, clinical and non-clinical specialists, statisticians, and medical writers to provide regulatory input and contribute to project decisions.

Within the regulatory team you will monitor for new legislation, guidelines and industry trends for all phases within clinical development and engage in active discussions on internal positions. You will be part of process and improvement projects both within Regulatory Affairs and across Zealand Pharma.

Qualifications:

The ideal candidate will have the following qualifications, but other areas of experience may also be relevant:
• degree within Life Science, Health Science, or a related area
• years of regulatory experience in similar position, from the pharmaceutical industry or Health Authority
• of working on projects in the clinical development phase
• IT/digital skills and experience with Veeva Vault
• in written and spoken English
• and engaged personality with a high team-spirit and willingness to support colleagues

Bonding to innovate

Our employees are fundamental to our success, and we continue to be able 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.

Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.

We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.

We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.

The Zealand Pharma 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.

Let’s bond and be bold

We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our 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 https://www.zealandpharma.com/careers/zealand-as-a-workplace/

Interested? Please apply no later than May 24, 2024, or as soon as possible. The applications will be reviewed as they come in.

For further information, please contact Vice President, Christina Balslev Rindshøj on CBRindshoej@zealandpharma.com.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to reach our goals bonding is at the core of everything we do. Let it be discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. This has led to more than 10 drug candidates invented by Zealand having 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 bond with us through LinkedIn or Twitter @ZealandPharma
Søborg Denmark

salary-criteria

Apply - Regulatory Affairs Clinical Specialist Søborg