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Regulatory Support

2 weeks ago

United States Axiom Software Solutions Limited Full time

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.