Job Type:
Full Time
Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences
Skills:
Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding,
Job Description
We are looking for a Regulatory Associate. The successful candidate will:
Be responsible for publishing, dispatching, and archiving Regulatory Submissions in agency recommended formats
Ensure the timely delivery of high-quality Regulatory Submissions following client and internal processes.
Prepare submission ready documents for electronic submissions including formatting, hyperlinking, and processing MS Word and Adobe Acrobat documents
Develop and maintain up-to-date knowledge of established agency standards and procedures for Regulatory Submissions.
Troubleshoot document issues with Adobe Acrobat and MS Word
Manage technical aspects for assigned submissions and status updates
Collaborate with various departments for planning, preparation, publishing and quality control checks of submissions.
Have prior experience and knowledge using various Publishing and Validation tools
Desirable Skills and Experience
Experience in Publishing and Submissions is required
