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Regulatory Affairs Consultant

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Boston, Massachusetts, United States Capgemini Full time
Regulatory Affairs Consultant

Capgemini is seeking a highly skilled Regulatory Affairs Consultant to manage and optimize our regulatory information management processes using the Veeva Vault RIM platform. The ideal candidate will have a strong background in regulatory affairs, experience with Veeva solutions, and a deep understanding of compliance requirements within the pharmaceutical or biotechnology industry.

Key Responsibilities:
  • Assist the sales team with pre-sales technical knowledge and presentations.
  • Understand customer requirements and provide sales support.
  • Conduct product demonstrations, both online and face-to-face.
  • Identify and understand the specific needs of clients.
  • Design and develop tailored solutions that meet client requirements.
  • Prepare and present proposals to clients.
  • Respond to technical and functional product queries during the sales process.
  • Work closely with the sales team and other departments to ensure coordination and smooth execution of sales processes.
  • Train the sales team on the technical aspects of the product or service.
Regulatory Information Management:

Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM. Ensure that regulatory submissions comply with applicable local and international regulations and guidelines. Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents.

System Configuration and Maintenance:

Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows. Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution.

Data Management:

Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones. Implement data governance practices to maintain compliance and quality of regulatory data.

Cross-Functional Collaboration:

Collaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions. Act as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities.

Process Improvement:

Identify opportunities for process enhancements and automation within the regulatory submission process. Develop and implement standard operating procedures (SOPs) for the use of Veeva Vault RIM.

Regulatory Compliance:

Stay updated on regulatory changes and ensure that the organization's processes and systems comply with current regulations and industry best practices. Participate in audits and inspections as necessary, providing documentation and system access as required.

Job Requirements:
  • Strong understanding of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM.
  • 5+ years of experience in Veeva RIM Submissions and submissions archive, Registrations and Publishing.
  • Veeva Vault admin certification is required.
  • Experience with Veeva RIM Connectors is preferred.
  • Good Presentation skills for conducting product demonstrations.
  • Excellent analytical and problem-solving skills, with attention to detail and accuracy.
  • Strong communication and interpersonal skills, with the ability to work collaboratively across teams.