Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
- Compiling, reviewing and validating eCTD sections of registered product as per the company standards
- Ensuring planning and proper organization of activities in collaboration with LOCs in line with the overall project plan and regulatory affairs milestones
- Managing multiple assignments, defining and agreeing strategy, completing data assessment to ensure authored CMC dossiers are fit for purpose
- Communicating regularly with your line manager to help identify any issues with business impact
- Ensuring information submitted in marketing applications meets regional requirements, allowing maximum flexibility with minimal unanticipated questions.
- Interacting with global regulatory groups and local operating companies to deliver high quality dossier on time
- Providing support to the GRL via authoring, input and/or critical review of one or more specific sections (technical/nonclinical and/or procedural) of regulatory documents
Job Requirements
- Proficient level of written and spoken English language
- Knowledge of regional laws and regulations relating to pharmaceutical product registration
- Awareness and understanding of eCTD requirements
- Prior experience in Regulatory Affairs is preferable(1-3 years).
- Prior experience in authoring, compiling and/or validating module 3 CTD/eCTD dossiers is preferable.
