Senior Regulatory Publishing Specialist

Job Title: Senior Regulatory Publishing Specialist

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.

Qualifications:

Education: Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field.
Experience: Minimum 3-6 years of hands-on experience within the CRO/Biotech/Biopharma industry.
Expertise: 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.