Regulatory Compliance Support Consultant

We are in urgent need of three more candidates for client review. The selected candidates must be local or semilocal to the Basking Ridge NJ area as proof of location is mandatory. Please note that only physical copies of a drivers license or a physical bill (no digital formats will be accepted) will be used for proof of location. This is a remote position but candidates must meet the location requirements.

This position will be filled quickly so please ensure that you read the full job description and match the mandatory requirements. We are seeking candidates with pharmaceutical and regulatory compliance experience particularly with exposure to FDA inspections internal audits and the Veeva RIM Submission/Archive system. The consultant will be responsible for ensuring compliance with regulatory standards and supporting crossfunctional teams.

• Accepted: USC GC GCEAD Canadian TN
• GCEAD candidates must provide proof for verification
• Important: For any visa candidates please be clear that the customer will not provide letters of employment under any circumstances.

• Regulatory Compliance: Ensure compliance with company SOPs (Standard Operating Procedures) and regulatory agency guidelines (e.g. FDA regulations).
• Crossfunctional Representation: Represent Regulatory Affairs in crossfunctional project teams providing technical expertise on submissionrelated documents.
• Veeva RIM Submissions: Work with Veeva RIM Submission/Archive tools and support the business needs related to document submissions archiving and publishing.
• Communication: Collaborate effectively with crossfunctional teams including Regulatory Affairs Clinical Operations Quality Assurance and Validation teams to manage the lifecycle of submission documents.
• Submission Management: Gather and prepare necessary documentation for regulatory submissions ensuring full compliance with all applicable regulations and guidelines.
• Documentation Review: Conduct thorough reviews of submission documents to ensure accuracy consistency and compliance with FDA and global regulatory requirements.
• Audit Support: Provide support during internal and external audits and FDA inspections.
• Change Management: Participate in Change Management processes gathering requirements and qualifying changes as they arise.
• Process Development: Assist in the creation and improvement of processes such as SOPs work instructions templates and checklists for regulatory operations.
• Regulatory System Access: Consistently manage access and change requests for regulatory systems and tools.
• Business Process Improvement: Communicate potential business process improvements or changes and provide regular status updates.

• Pharmaceutical Experience: 510 years of experience in a pharmaceutical environment.
• Regulatory Compliance: Extensive experience in a regulatory environment with exposure to FDA inspections and internal audit processes.
• Veeva RIM Submission/Archive: Handson experience working with Veeva RIM tools for submission archiving and publishing of regulatory documents.
• Compliance Knowledge: Comprehensive knowledge of GxP FDA regulations and global regulatory submission standards.
• Attention to Detail: Ability to review complex documents with precision and propose proactive solutions to any regulatory issues.

• Education: Bachelors degree in Life Sciences or a related field.
• Experience: 5 to 10 years of experience in the pharmaceutical industry with a strong focus on regulatory environments.
• FDA and Regulatory Knowledge: Highlevel exposure or handson experience with FDA inspections and internal audits.
• Veeva RIM System: Familiarity with Veeva RIM Submission/Archive systems is a must.
• Communication Skills: Excellent written and verbal communication skills as well as strong presentation skills are essential.
• Collaboration: Ability to work effectively with crossfunctional teams across different departments.

Please submit the following details in the exact format below. Incomplete profiles will not be considered for this position:

Note:

• Drivers License: A copy of the candidates drivers license (or a physical bill) is required for proof of location. Digital copies will not be accepted.
• Chart Submission: The chart above must be submitted exactly as shown.