The Principal Regulatory Affairs Assistant position is a fully remote, full-time role based in India, with job ID R-01277179, under the Clinical Research category. This position is within a global Contract Research Organization (CRO) specializing in clinical research services. The team is responsible for advancing drug development efforts to address pressing health concerns globally. Key duties involve administrative, contractual, and financial support, along with project management and regulatory compliance tasks, particularly in line with the European Union Clinical Trials Regulation (EUCTR).
Key Responsibilities:
- Regulatory Compliance & Documentation: Prepare and submit regulatory documentation following EUCTR guidelines.
- Project Management: Manage project deliverables, update project status, and ensure timely delivery while liaising with internal and external clients.
- Administrative Support: Provide advanced support to upper management, maintain SOP knowledge, and track project plans.
- Bids & Proposals: Assist in the preparation of bids, proposals, and contract modifications, and analyze related data.
- Collaboration: Work with project teams to mitigate issues and ensure smooth delivery.
Requirements:
- Education: Bachelor’s or Master’s degree or equivalent academic qualification.
- Experience: 3+ years of relevant experience.
Key Skills:
- Organization & Planning: Ability to handle shifting priorities.
- Documentation & Proposals: Strong understanding of contract and proposal documents.
- Technical Proficiency: High proficiency in Microsoft Office and electronic document production.
- Communication & Interpersonal Skills: Outstanding written and verbal communication with exceptional attention to detail.
- Multitasking & Pressure Management: Capable of handling multiple tasks efficiently under pressure.
This role emphasizes a balance of regulatory affairs expertise, project management, and strong interpersonal and technical skills. If you meet the qualifications and are interested in regulatory support within clinical research, this could be a suitable fit.