Сотрудник по вопросам регулирования в SPECTRAFORCE

Отправьте личное сообщение участнику, разместившему вакансию от лица компании SPECTRAFORCE Keshav Bharti Keshav Bharti Senior Recruiter at Spectraforce Technologies • Job title: Regulatory Affairs Associate• Location: 100% remote• Duration: 12 months (possible extension)Top Must Have Skill Sets:• Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance, including familiarity with the US Certificate of Pharmaceutical Product (CPP) process.• Basic understanding of the Veeva RIM Vault system• Good written and verbal communication skills• Independent time management and prioritization skills and detail-oriented• Critical thinking skillsJob Details:• Ensure the smooth compliant flow of information between all Functional areas, internal and external to GRAAS, local offices, external partners, and regulatory authorities.The type of qualities/characteristics the hiring manager is looking for in candidates that will work best with their team:• Works well collaboratively, as there is a lot of teamwork involved in what we do.• Detail-oriented, to be able to monitor data quality.• Comfortable learning new systems/processes. Someone who can follow instructions/guides, since we work in a framework based on rules/compliance.Top 3 qualities of the hiring manager's ideal candidate:• Good communication skills (verbal & written), resourceful critical thinker, detailed.• (Overall, we’d need someone who understands the importance of details, since we work so much with monitoring Data Quality, and someone who is able to communicate clearly with internal and external teams.• Once training is completed, this individual must then understand how to utilize the tools provided to complete needed tasks, which requires resourcefulness and critical thinking skills.)Basic Qualifications• Bachelor's degree OR Associate degree and 4 years of experience OR High school diploma /GED and 6 years of experienceDay to Day Responsibilities:• Maintain Regulatory document management and tracking systems.• Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence.• Responsible for maintaining the on-site US Certificate of Pharmaceutical Product (CPP) responsibilities, as well as hard copy pickup at the company and mailings.• Point of contact between Regulatory Representatives/CMC and publishing teams• Ensuring Regulatory compliance with SOPs and Regulatory authorities.• Provide support to RDA team members and other functional areas, including vendors• Collaboration with external partners/outsourced CROs.• Responsible for creating, running, and analyzing report data for potential Veeva RIM system clean-up. Show more Show less Должностной уровень Молодой специалист Тип занятости Договор Должностные обязанности Развитие бизнеса и Научная деятельность Отрасли Фармацевтическое производство и Исследования в сфере биотехнологий