Senior Regulatory Consultant (EU)

If you are a Regulatory Consultant with a strong background in the industry, you may be what we are looking for!

BASE life science is a business and technology consulting company working exclusively within the life science industry. We specialize in working on the customer side of technology projects and IT systems. We experience increased demand for our services for delivery of IT projects to our clients within the life science industry – from biotech start-ups to global pharmaceutical companies, across Europe.

At BASE we partner with industry leading solution providers, including Veeva, Salesforce and IQVIA and help to carve business value from digital platforms and data.

 

About the role

We are seeking Senior Regulatory Consultants with relevant working experience in the industry or as Consultant within Regulatory Business Processes, Data Management, Regulatory Information Management Systems, or as Regulatory Operations Managers, RIM Business Owners, and Regulatory Intelligence or Compliance SME’s.

Your main task will be to advise international pharma clients and to participate in projects for high profile clients – from initiation to completion. The ideal candidate has successfully completed the first projects and is eager to contribute to our growth at BASE.

The position can be based out of our different European offices in UK, Spain, Denmark, Switzerland, France, Italy, Germany or in our new office in East Coast of the US.

 

Who are you?

As a minimum, we expect you to have minimum 3 years’ proven experience in RIM Roles (or more), specifically:

• Deep understanding of the R&D processes in life science companies
• Successful track record of participating in IT or regulatory data management business projects in a life science or consulting company
• Ability to structure tasks, priorities and attention to details

Furthermore, the ideal candidate has:

• A BSc or MSc relevant to life science
• Knowledge of healthcare regulatory requirements (e.g., 21 CFR p. 11) and understanding of ICH-GxP
• Knowledge of regulatory systems (e.g., RIM, eCTD), and any other relevant systems like e-Quality Management Systems, e-Document Management Systems, e-Promotional Materials, etc.
• Customer Service mindset
• Strong communication and interpersonal skills with the ability to collaborate with stakeholders across all levels of the organization
• Ability to communicate effectively and clearly in English, both in writing and verbally
• Excellent analytics and problem-solving skills
• Excellent attention to details
• Ability to work independently and manage multiple projects simultaneously
• Ability to structure and present complex situations to a set of various stakeholders including executive levels
• Excellent MS Office skills

Lastly, we expect you to be willing to continuously build knowledge in the IT solutions and business areas where BASE is a leader, as we desire like-minded people who are curious and constantly seek new knowledge.

While our aim is to deliver most of our services remotely for workshops travel to customer sites may be required.

 

What do we offer

In short, we offer you an entrepreneurial and multi-cultural work environment, where you will be able to quickly make an impact for our customers. We also offer:

• Ongoing learning and development opportunities to grow your career
• An inspiring work environment with many social events
• A culture that values your family & private life as an enabler for your job performance
• You will be part of our mission to support our pharma customers better serving their customers … which are eventually the patients

 

Who we are

BASE life science is a business and technology consulting company founded in 2007. Working exclusively within the life science industry, we work very closely with the customer – in most cases, even on behalf of the customer-on-customer side.

From our offices in Denmark, Switzerland, France, Italy, Germany, UK, Spain and US, we serve customers across Europe – and beyond. Our clear focus on life science – based on our deep understanding of the local market – enables us to deliver tailored solutions that deliver significant value and lasting impact.

BASE partners with industry-leading solution providers, including Veeva, Salesforce and IQVIA and help to carve business value from digital platforms and data.

 

Interested?

Please contact Christine Hejlsborg Thernøe at chej@baselifescience.com or Arazazu Botto at abot@baselifescience.com if you have additional questions to the position.

If interested in the position, please upload your CV through our recruitment system. Only CV and applications sent via our recruitment system will be considered as applicants.