Sr Regulatory Publishing
Sr Regulatory Publishing
Posted on :
25-03-2025
Employer Active
1 Vacancy
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Job Description
Job Description: Sr Regulatory Affairs Publishing
Preparation Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets.
Publishing electronic regulatory submissions (eCTD).
Submission build activities creating interdocument links performing quality check and validating compiled submissions and finalizing submission by required dispatch date.
Coordinate & engage with RA Ops team for timely submissions / Publishing tasks.
Reviewing manufacturing documents like MFC BMR process validation Protocol/report stability protocol/report sampling protocol process validation protocol and PDR.
Preparation and review of response to Agencys queries and submission within the stipulated time given health authorities.
To develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects.
Qualifications:
Any Bachelors/Masters Degree (pref B Pharm/ M Pharam) or Any Life Science.
Exp: 712 years (Regulatory Publishing Submission ECTD)
Gap Analysis Hands of experience in publishing and Knowledge on CTD compilation
The ability to deal effectively with sponsors and internal customers at all levels.
Excellent communication and interpersonal skills both written and spoken.
communication,quality check,publishing,ctd,regulatory affairs,ectd,process validation,interpersonal skills,submission build,regulatory submissions,project coordination,protocol
Employment Type
Full Time
Key Skills
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