What are the responsibilities and job description for the Regulatory Support position at Axiom Software Solutions Limited?
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 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.
