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  A dynamic professional with around 5 years of experience in Regulatory Affairs Operations (Publishing) supporting diverse markets including US, Europe, Canada, and Australia.
  Proficient in handling Insight Publisher tool, EXtedo eCTD Manager, LORENZ docuBridge, validation tools and document publishing tools for over 5 years.
  Currently associated with Parexel Consulting as Associate – Regulatory Affairs.
  Comprehensive experience in publishing of module 4 and module 5 documents for US Submissions.
  Expertise in document publishing tools such as Acrobat Professional and ISI Toolbox for Bookmarking, hyperlinking, and making document submission compliant.


Highly motivated and tenacious professional with a strong track record of quality project outcomes and customer service. Assist with preparation, assembly, and quality checks of electronic and paper submissions for delivery to FDA and other regulatory authorities including: Advertising and Promotional material, INDs, NDAs, IND/NDA amendments, meeting requests, post-authorization changes (CMC, clinical), NDA/IND annual reports, and post-marketing submissions. Professional and trusted disposition has led to the creation and cultivation of highly effective teams, and unwavering client loyalty.

To utilize my technical skills for achieving the target and delivering the best performance in an esteemed organization I would like to implement my innovative ideas, skills, and creativity for accomplishing the projects.

Accomplished Electronic Document Specialist & Regulatory Submission Publisher with 8+ years of experience in end-to-end regulatory documentation and global health authority submissions. Expert in advanced MS Word formatting, Adobe Acrobat, PDF QC, and eCTD publishing. Proficient in regulatory publishing tools and electronic document management systems. Strong track record of ensuring accuracy, compliance, and on-time submissions while effectively coordinating cross-functional teams including Regulatory, Clinical, and Medical Writing.

Tristan Hyppolite

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Regulatory Publishing Consultant

Data Entry Specialist

Education

Bachelor of Science - Biology

High School Diploma -

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Regulatory Publishing Consultant

Data Entry Specialist

Bachelor of Science - Biology

High School Diploma -

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