Senior Regulatory Consultant

March 14

Apply Now

Receive Emails with Similar Jobs

BASE life science

WebsiteLinkedInAll Job Openings

BASE life science is a consulting firm specializing in providing data-driven solutions to transform the life sciences industry. Their services cover the entire life sciences value chain, from research and development to commercial operations. With a focus on data migration, engineering, advanced analytics, and AI, BASE life science helps clients achieve greater success through innovative and smart solutions. They collaborate with major technology partners to drive excellence and impact for over 120 life sciences clients through more than 1,500 successful projects.

Regulatory Affairs • R&D • Implementation • RIMS • EDMS

201 - 500 employees

📋 Description

• Provide expert guidance, training, and support to end-users. • Contribute to the development and maintenance of critical regulatory documentation. • Serve as a subject matter expert in Veeva Vault RIM. • Provide comprehensive end-user support and troubleshooting. • Develop and execute Veeva Reports to analyze regulatory data. • Keep documentation up to date reflecting regulatory changes. • Apply a strong understanding of regulatory affairs principles. • Monitor and interpret regulatory changes and communicate impact. • Identify opportunities to improve regulatory processes and workflows. • Participate in regulatory audits and inspections as required.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.