Regulatory Support

1 month ago

Ridge, United States Magicforce Full time
  • 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.

Job Title: Consultant

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.
  • Knowledge or exposure on Veeva RIM Submission/Archive Publishing etc.

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 Veeva Submissions/Archive team 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.

Veeva,pharmaceutical

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