Regulatory Affairs Junior Specialist

With a startup spirit and 90,000 curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us. Inviting applications for the role of Regulatory Affairs Junior Specialist We currently have an opportunity for a graduate-level consultant from any degree discipline. This role will offer candidates the opportunity to gain knowledge and experience in SOPs Compliance and Management systems. You will work autonomously within a team environment and work on various projects with exposure to some of the world’s leading pharmaceutical companies. We offer full training to help shape your career within our company. Please note, in addition to this, we will also offer extensive training/support to help shape your career within our company. Responsibilities: • Complete 1:1 consultation session with the appropriate global author(s) to achieve a high-level review of the key updates to the Clinical Medical and Controlled Documents (CMCD). • Work in collaboration with local authors and approvers to review/update their local work instructions (WI’s)/required forms (RFs) to ensure they align with the new global CMCD requirements, by the set deadline date. • Support the 2-year assessment process by identifying those CMCDs that require assessment and notify the document owners of their responsibilities. • Review and approve all assessments, change requests and retirements for the local submitters via UIMs. • Track all central reviews/assessments through the appropriate spreadsheets and databases throughout each stage of the process for metrics purposes. • Resolve any issues that arise throughout the review process in an effective and professional manner. • Work closely with the clients global SOP Team/ Management team to successfully create, implement and stream