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

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.