Senior Regulatory Consultant

The life sciences industry plays a significant role in advancing healthcare and improving the quality of life - in many cases, saving millions of lives globally. At BASE life science, this is the motivation for everything we do, aimed at pushing boundaries, seeking excellence, and making a lasting difference through consulting expertise and data-driven solutions.

Who is BASE life science?

Founded in 2007, BASE life science is a business and technology consulting enterprise working exclusively in the life sciences industry.

From our headquarters in Denmark and offices in France, Germany, Italy, Spain, Switzerland, the United Kingdom, and the United States of America, we serve customers across the globe. With a deep understanding of the life sciences industry, we work hand in hand with customers to identify, develop, and implement strategic initiatives that drive growth, efficiency, and overall success through tailored solutions.

Our partnership with industry-leading solution providers, including Veeva, Salesforce, IQVIA, Benchling, and MediSpend ensures that our clients harness the full potential of the most innovative solutions on the market.

About the role

This role will be instrumental in providing expert guidance, training, and support to end-users, as well as contributing to the development and maintenance of critical regulatory documentation.

As a Senior Regulatory Consultant your responsibilities include:

Veeva Vault RIM Expertise:

• Serve as a subject matter expert in Veeva Vault RIM (Regulatory Registrations, Submissions, Submissions Archive, etc.).
• Provide comprehensive end-user support, troubleshooting, and guidance on Veeva Vault RIM functionalities.
• Configure and maintain Veeva Vault RIM to ensure alignment with regulatory requirements and business processes.
• Develop and execute Veeva Reports to analyse regulatory data and generate actionable insights.
• Preferably Veeva Vault Platform certified.

Training and Documentation:

• Develop and maintain training materials, including Quick Reference Cards (QRCs), guidance documents, and Standard Operating Procedures (SOPs), related to Veeva Vault RIM and regulatory processes.
• Conduct training sessions for end-users to ensure effective utilization of Veeva Vault RIM.
• Keep documentation up to date to reflect changes in regulatory requirements or system updates.

Regulatory Affairs Expertise:

• Apply a strong understanding of regulatory affairs principles, procedures, and regulations in the EU, US, and RoW (Rest of World).
• Provide high-level regulatory guidance and support to internal teams.
• Monitor and interpret regulatory changes and updates, and communicate their potential impact to stakeholders.

Process Improvement:

• Identify opportunities to improve regulatory processes and workflows.
• Collaborate with cross-functional teams to implement process improvements and ensure compliance.
• Participate in regulatory audits and inspections, as required.

We offer this position in United States.

What makes you the best person for this job?

We are seeking an experienced Senior Regulatory Consultant to join our growing team. The ideal candidate will possess a strong background in regulatory affairs, with a particular focus on leveraging Veeva Vault RIM to streamline and optimize regulatory processes.

On top of this, you have the following competences:

• Bachelor's or Master’s degree in a Science or related field with relevant experience.
• Minimum of 6+ years of experience in regulatory affairs, preferably within the pharmaceutical, biotechnology, or medical device industry.
• Extensive experience using and providing end-user support for Veeva Vault RIM (Regulatory Registrations, Submissions, Submissions Archive, etc.).
• Proven ability to create and update training materials, including QRCs, guidance documents, and SOPs.
• Strong experience in creating Veeva Reports.
• Solid understanding of regulatory regulations and procedures in the EU, US, and RoW.
• Preferably Veeva Platform certified.
• Excellent communication (written and verbal), interpersonal, and problem-solving skills.
• Ability to work independently and as part of a team.
• Strong attention to detail and organizational skills.

What makes us the best employer for you?

BASE life science has been recognized as an outstanding workplace, earning us the Great Place To Work certification in Denmark, France, Germany, Italy, Spain, Switzerland, and the United Kingdom.

We are proud to represent 35+ nationalities among our colleagues, and firmly believe in the power of diverse perspectives and characteristics to drive truly innovative solutions and achieving excellence.

At the heart of our organization lies a foundation grounded in five core values: team spirit, trust, openness, ambition, and execution. We cultivate an environment that champions flexibility, placing confidence in our employees to successfully complete tasks while upholding a healthy work-life balance. Additionally, we place significance in cross-functional collaboration, where niche skills and specialisms are valued and challenging the status quo is encouraged.

Additionally, we offer you:

• Health insurance.
• Remote work friendliness.
• Ongoing learning and development.
• Flexible schedules to fit your work to your routine.
• Contributions to physical, social, and emotional health.
• Home office setup with laptop and other electronic devices.
• The chance to help make a difference for patients around the world.

Interested?

If you find this position intriguing, don't delay—submit your application in English at your earliest convenience. We are continuously reviewing and assessing all incoming candidates and eagerly await your application.

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