Quality & Compliance
Safety & Vigilance
02 november 2023
Our Submission Managers are responsible for planning, managing, and tracking regulatory submissions. They provide regulatory operations expertise to cross-functional submission project teams, which helps to promote and bring excellence in the planning, preparation, and delivery of regulatory submissions. They act as the primary point of contact for submissions.
Our Submission Managers collaborate with the Regional Regulatory Lead and Local Regulatory Authority to ensure the delivery of compliant submissions to global health authorities on time.
Each of our Submission Managers is handpicked to possess the below-mentioned quality to smooth the process for our clients.
Our Submission Managers have Leadership Qualities to lead multi-functional teams and build strong, productive relationships across the organization. They have excellent communication skills to successfully lead submissions to completion, from Kick-off Meetings to stakeholder meetings to de-block any blocking points to follow up on submissions. They have strong organizational and problem-solving skills and can prioritize workload with limited instruction. They are Technical Experts with strong RA backgrounds and experience in Life cycle management activities, Clinical, and MAA to plan, organize, and communicate with stakeholders. Submission Managers at PLG are adept in Time Management and juggling multiple schedules; they are trained to anticipate roadblocks before they occur. They are Problem Solvers and are objective, can analyze facts, and evaluate options. They are capable of solving complex problems for submissions. Their Strategic Thinking, Proactive approach, and use of critical thinking skills to de-block any blocking points for submission make them excellent in their jobs.
Submission Managers at PLG plan our clients’ Regulatory activities and road-mapping product lifecycle. They manage Regulatory Information and generate metrics for planning and oversight using tools provided by clients. They track upcoming and ongoing activities and report the same to our clients. They support and coordinate Kick-off Meetings and any subsequent meetings once the strategy is confirmed. They support the client Global Regulatory Lead (GRL) and submission teams to deliver the strategy. They monitor submission progress and set deadlines to ensure timely submission by collaborating with the regional and local representative(s). They de-block any blocking points. They follow up on submission dates and milestones and provide timely feedback to the Global Regulatory Team (GRT) client. They coordinate submission content assembly with contributing functions, regional local representatives, and publishers.
Submission Managers at PLG work with experts at all levels, either in client environments or using in-house tools. They collaborate with Global Regulatory Team members, the Local Regulatory Affairs Department, and Subject Matter Experts to meet the regulatory’s toughest challenges head-on. Our Submission Managers have a Global understanding of executing Clinical Applications, MAA, and Life Cycle Management of RA Procedures, including but not limited to Renewals, CMC Variations, Safety Variations, PSUR, etc. They have excellent knowledge of the drug development process and can maintain the overall regulatory roadmap, regulatory information, and quality aspects for our clients.
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