Regulatory Affairs Specialist
4 days ago
Responsibilities:
Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.
eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards.
Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch.
Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks.
Manufacturing Document Review: Review critical manufacturing documents such as MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol, and PDR.
Response to Agency's Queries: Prepare and review responses to regulatory agencies' queries, ensuring timely submission within stipulated deadlines.
Regulatory Submissions Development: Develop and deliver comprehensive regulatory submissions within agreed-upon timeframes, providing crucial regulatory support to project teams for assigned projects.
Education:
Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field.
Experience:
2 - 4 years of hands-on experience within the CRO/Biotech/Biopharma industry.
Demonstrated expertise in gap analysis, publishing, and knowledge of CTD compilation.
Communication Skills:
Excellent communication and interpersonal skills, both written and spoken, with the ability to effectively interact with sponsors and internal stakeholders at all levels.
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