Sr. Regulatory Publishing Specialist
Sr. Regulatory Publishing Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
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 Agencys 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: Bachelors/Masters 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.
regulatory submissions,excellent communication,technical document preparation,ectd publishing,actd,ctd,interpersonal skills,gap analysis,regulatory publishing,common technical document (ctd),publishing,manufacturing document review,quality checks
Employment Type
Full Time
