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Regulatory Support

Regulatory Support

Axiom Software Solutions LimitedJersey City, NJ, US
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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

Requirements

Mandatory skills :

  • 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

JD details :

  • Ensure compliance with company Standard Operating Procedures and regulatory agency regulations / guidance.
  • Represents 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.

    • 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.
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