For Professionals

Pick your region

Search Profiles by Job Title

ENGLISH IN

ENGLISH UK

Deutsh

Español

Français (canada)

Français (france)

italiano

polski

português (brasil)

Login

Notifications

Show my Profile

Edit My Profile

Settings

Contact us

Sign Out

My Account

GO TO DASHBOARD

GO TO PROFILE

CREATE YOUR PROFILE

cta_buttons

Dashboard

Profile Editor

Search

Messages

Skills

Location

School

Company

Name

Search By

Contact Us

Terms of Use

Blog

Accessibility

Privacy Policy

Fraud Awareness

Cookie Policy

About Us

Sitemap

Do Not Sell or Share My Personal Information

All Regions

Bold.pro

Facebook

Instagram

Youtube

Pinterest

How it works

For Employers

Consultant

Photo

Contact

Overview

Professional Experience

Education

Timeline

Tell them why you're reaching out:

I am contacting you because * :

I am contacting you to:

Edit basic information displayed on your Profile

Contact Info

Don't wait! With a free professional profile on Bold.pro you can:

Check your email for submission confirmation and future notifications.

The person you’re trying to reach has disabled the Contact Request option

Contact request cannot be submitted

Success!

Your request is on the way!

Cast a wider net to find even more talent for your team. Start by exploring these profiles.

Cast a wider net to find even more talent for your team. Explore more profiles to find your next great hire.

Cast a wider net and connect with like-minded professionals. Start by exploring these profiles.

Cast a wider net and connect with like-minded professionals. Explore more profiles to grow your network.

You might have mistyped the address or the page has moved.

If you got there from another site, we'd appreciate if you

The Bold Profile you're looking for is no longer available.

We've integrated with our largest Resume Building website, MyPerfectResume, to help you build a professional Bold Profile. Once finished, your Profile will appear on Bold.pro.

You will be redirected from Bold.pro to MyPerfectResume

Associate Principal Engineer

Use our expert recommendations below to get started.

Tell us about your accomplishments

Add anything else you want to know.

Additional information

What are your affiliations?

Select time slots on the calendar below

When are you available to work?

Fill out this section or it will be deleted

This section can't be empty

What skills would you like to highlight?

Showcase your certifications.

What certifications do you have?

Tell us about your {sectionName}

What interests do you have?

What languages do you know?

Focus on your years of experience or amount of courses you have completed.

Showcase your career overview

Highlight your full skillset on your Bold Profile

Show your skills

What software skills do you have?

Briefly tell us about your background

Share your contact information with {name}

See my work availability

Availability

Available

University Overview

Job overview

Hi, I’m

Not Available

If you plan to reach out about a job, feel free to let me know so I don't miss your message.

Bold Profiles Footer Logo

Job Title

Bold Profiles

By filling out this form, you consent to being contacted and agree to our

Desired Job Title

Work Preference

WORK PREFERENCE

Job Search Status

Location Preference

Important To Me

Work Location

Work Type

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.

Highly motivated employee with desire to take new challenges. Strong work ethic, adaptability and good interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills. Working since August 2017 to till date as a regulatory professional. Total 6.4 years of experience in DMF, ANDA, IND and NDA (s) pre and post approval filings. Completed bachelor’s in pharmacy during the academic year September 2012 to May 2016.


  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.


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

Overview

Work History

Regulatory Publishing Consultant

Data Entry Specialist

Education

Bachelor of Science - Biology

High School Diploma -

Timeline

Regulatory Publishing Consultant

Data Entry Specialist

Bachelor of Science - Biology

High School Diploma -

Similar Profiles

Kelly BechterKelly Bechter

Pavan Kumar BoorluPavan Kumar Boorlu

ANUSHANANDINI DEVARAKONDAANUSHANANDINI DEVARAKONDA

Sumedha Sameer BhokareSumedha Sameer Bhokare