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Sr. Regulatory Publishing Specialist

Sr. Regulatory Publishing Specialist

Makro Group

7 - 10 years

5 - 7 Lacs

Hyderabad Madhapur Telangana

Posted:1 week ago| Platform:

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Skills Required

Regulatory Publishing Team Management USFDA CTD fda eCTD Publishing Submission Build Activities ACTD

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Work from Office

Job Type

Full Time

Job Description

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. Location - Madhapur, Hyderabad, Telangana, India 500081

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Makro Group

makrogrp.com/

IT Services and IT Consulting

Princeton New Jersey

501-1000 Employees

43 Jobs

Key People

John Doe

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Jane Smith

CFO
Emily Johnson

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