Key Responsibilities of a Regulatory Operations Professional:
Document Management and Submission:
Preparing, compiling, and managing regulatory submissions (e.g., INDs, NDAs, MAAs) in both paper and electronic formats.
Ensuring submissions adhere to specific regulatory guidelines and are compliant with electronic submission standards (e.g., eCTD).
Maintaining and updating submission components, including templates and procedures.
Quality Control and Assurance:
Performing quality reviews of regulatory documents to ensure accuracy and compliance.
Identifying and resolving discrepancies or issues in submissions.
Project Management and Coordination:
Managing the workflow of regulatory submissions, including timelines and deadlines.
Collaborating with internal teams (Regulatory Affairs, Clinical, etc.) and external stakeholders (regulatory agencies, vendors).
Tracking project progress and reporting on key metrics.
Process Improvement:
Contributing to the development and implementation of new processes and systems to improve efficiency and quality of regulatory operations.
Participating in process improvement initiatives and identifying areas for optimization.
1.The more the Jobs you apply, the higher your chances of getting a job.
2. Keep your profile updated Update
Recruiters prefer candidates with complete profile information.
3. Keep visiting the Teamlease.com daily
Daily visit will ensure you won’t miss out on any Job opportunity.
4. Watch videos to improve Watch videos
Be a better candidate than others by watching these Job-related videos.