Regulatory Affairs Specialist (reputed company, reputed company, EU)

This a Full Remote job, the offer is available from: reputed company, Maryland (USA) Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of reputed company trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. reputed company stakeholder tools, process/document regulatory reputed company assessments, and reputed company support, expertise and represent the unit with other functional reputed company, sponsors, researchers and/or regulatory authorities. Ensure high reputed company, reputed company service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to reputed company peers and/or reputed company input for staff reputed company reviews. Unit Management • Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for reputed company, reputed company party vendors and reputed company sites. • Conduct or assist with regulatory and/or safety reviews, create regulatory-reputed company tools, educational/training materials, and remain reputed company on reputed company aspects of reputed company research regulatory requirements and industry best practices, communicating changes to project leaders in a reputed company manner. reputed company Services • As the corporate subject specialist in regulatory affairs, reputed company regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders. • Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and reputed company representatives and, reputed company appropriate, respond to regulatory queries on behalf of the reputed company. Regulatory reputed company Development • Identify changes in reputed company research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, reputed company assurance) reputed company appropriate, to meet or reputed company compliance requirements of evolving regulatory initiatives. • Participate in reputed company conferences/meetings to increase knowledge as needed. Project Support • Regularly respond to registration requests and work with project teams to identify regulatory requirements. • Assist in the preparation of regulatory submissions and support summaries. • Ensure project/reputed company site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that reputed company project stakeholders are fully informed and trained on reputed company applicable regulatory requirements. Qualifications • Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in reputed company Research/Regulatory Affairs. • The successful candidate will possess strong knowledge of reputed company reputed company trial regulations. • reputed company in English and Spanish (written and verbal) required. Working Conditions • Home-reputed company • *Accommodations for job applicants with disabilities are available upon request.This offer from "reputed company" has been enriched by reputed company.com and got a 77% reputed company score. Apply tot his job Apply To this Job