Regulatory Support

Summary

Join our team as a Regulatory Support Consultant in Basking Ridge, NJ with a remote option! This role requires experience in pharmaceutical and regulatory environments, including FDA inspections and internal audits. You will ensure compliance with SOPs and regulations, represent Regulatory Affairs on project teams, and provide technical expertise. Responsibilities include document lifecycle management, collaboration with cross-functional teams, and maintaining knowledge of regulatory requirements. A Bachelor's degree in a life science field and 5-10 years of relevant experience are required.

Requirements

• Experience in pharmaceutical environment
• Experience in regulatory environment is required
• High level exposure or knowledge about FDA inspection and internal audit process
• Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc
• Bachelors’ degree, preferably in a life science or a related field
• 5 to 10 years of experience in pharmaceutical environment
• Excellent written, verbal communication and presentation skills

Responsibilities

• Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance
• Represent Regulatory Affairs on cross-functional project teams
• Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents
• Work with subject matter experts, and cross functional departments to support business needs
• Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation
• Gather and assemble information necessary for submissions in accordance with regulations/guidance
• Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary
• Conduct review of published submissions to ensure consistency and compliance with regulatory requirements
• Maintain knowledge of local and global regulatory submission requirements
• Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives
• Provide Regulatory Affairs support during internal and external audits and inspections
• Exposure in Change management process, requirement gathering, qualifying the changes etc
• Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc
• Consistently support for regulatory systems access and change management
• Responsible for communicating business process improvements, business related issues, status updates or opportunities

Preferred Qualifications

Bachelors’ degree, preferably in a life science or a related field