Are you looking to be a part of a team that plays a pivotal role in bringing life-saving cures to market? As a Regulatory Affairs Assistant working remotely in India, you’ll support a team of experts in clinical research, contributing to the development of groundbreaking drugs. This position is part of the PPD® clinical research portfolio, which is a leading global contract research organization (CRO) at the forefront of innovation in the pharmaceutical industry.
Key Responsibilities
As a Regulatory Affairs Assistant, your role will encompass a variety of tasks designed to streamline department processes and ensure that regulatory documentation is well-organized and accessible. Key responsibilities include:
- Administrative Support: Assisting the department with travel arrangements, expense coordination, meeting planning, and preparing presentations.
- Document Management: Managing document archiving and retrieval processes. This includes maintaining archive areas for departmental processes, training documents, job aids, and regulatory metrics.
- SOP/WPD Management: Assisting in the management and revision of Standard Operating Procedures (SOPs) and Work Process Documents (WPDs).
- Website Maintenance: Supporting updates to the department’s webpage and ensuring content is accurate and current.
- Resource Management: Assisting in the maintenance of utilization and resourcing tools, ensuring that resources are efficiently allocated.
- Submissions Support: Archiving documents and submissions to ensure compliance with regulatory standards.
Work Schedule & Environment
- Schedule: Standard Monday to Friday.
- Work Environment: Remote with the flexibility to work in an office-like setting.
Qualifications
To be successful in this role, you will need:
- Education: A high school diploma or an equivalent vocational qualification. Additional certifications may be required for technical positions.
- Experience: At least 2 years of prior experience in a similar role, ideally within the pharmaceutical or clinical research industry.
- Skills: Excellent organizational skills, attention to detail, and the ability to manage multiple tasks simultaneously. Familiarity with document archiving and the regulatory process is a plus.
