Regulatory support

Job Title : Regulatory Support

Location : Basking Ridge NJ

Remote Option : Yes. But the candidate should be available to attend customer meetings twice in a month

Mandatory skills :

• 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.

Job Title : Consultant

JD details :

• Ensure compliance with company Standard Operating Procedures and regulatory agency regulations / guidance.
• Represents Regulatory Affairs on crossfunctional project teams.
• Provide technical expertise to crossfunctional teams on managing the lifecycle of submissionrelated documents.
• Work with subject matter experts and cross functional departments to support business needs.
• Effectively communicate and work collaboratively with crossfunctional 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.

Qualifications :

• Bachelors’ degree preferably in a life science or a related field
• 5 to 10 years of experience in pharmaceutical environment.
• Experience in regulatory environment is required.
• Excellent written verbal communication and presentation skills.
• High level exposure or knowledge about FDA inspection and internal audit process.

Last updated : 2024-11-15