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.