Image of Traci Williams

Traci Williams

Submission Management Coordinator

Regulatory Affairs Manager at AstraZeneca

Pennsville, New Jersey

Section title

Traci Williams's Email Addresses & Phone Numbers

Traci Williams's Work Experience

AstraZeneca

Submission Management Coordinator

January 2013 to August 2014

AstraZeneca

Associate Regulatory Affairs Manager

January 2010 to January 2013

AstraZeneca

Administrative Coordinator

January 2000 to January 2010

Traci Williams's Education

Wilmington University

Bachelor's degree Business Administration and Management General

2006 to 2008

Wilmington University, DE

Bachelor of Science (B.S.) Organizational Management 3.93

2006 to 2008

Traci Williams's Professional Skills Radar Chart

Based on our findings, Traci Williams is ...

Open-minded
Inspirational
Communicator

What's on Traci Williams's mind?

Based on our findings, Traci Williams is ...

50% Left Brained
50% Right Brained

Traci Williams's Estimated Salary Range

About Traci Williams's Current Company

AstraZeneca

Managed and provided all clinical trial documentation to the marketing company for a Saudi Arabia submission within a 48 hour time line for a high priority product, meeting the health agency’s deadline. Designed and built migration SharePoint web site for regulatory and submission management group. Initial time frame for project was 3 weeks the project was moved...

Frequently Asked Questions about Traci Williams

What company does Traci Williams work for?

Traci Williams works for AstraZeneca


What is Traci Williams's role at AstraZeneca?

Traci Williams is Submission Management Coordinator


What is Traci Williams's personal email address?

Traci Williams's personal email address is tr****[email protected]


What is Traci Williams's business email address?

Traci Williams's business email addresses are not available


What is Traci Williams's Phone Number?

Traci Williams's phone (201) ***-*361


What industry does Traci Williams work in?

Traci Williams works in the Pharmaceuticals industry.


Who are Traci Williams's colleagues?

Traci Williams's colleagues are Daisy Wang, peter schweikert, Liangliang Huang, Jerry XU, jane huang, Thomas Pan, Qianqian Han, Annie Ma, Michael M.D., and Fen Wang


About Traci Williams

📖 Summary

A regulatory professional with 14 years experience in US submissions for mature and emerging products. Also over 20 years of Executive Assistant experience. Bachelor of Science Business Organization Management with emphasis in regulation, project management and leadership capabilities. Highly motivated with an eye for detail and skilled in complex project management.Submission Management Coordinator @ Managed and provided all clinical trial documentation to the marketing company for a Saudi Arabia submission within a 48 hour time line for a high priority product, meeting the health agency’s deadline. Designed and built migration SharePoint web site for regulatory and submission management group. Initial time frame for project was 3 weeks the project was moved up to 3 days. I met the deadline and site was operational. Assisted Head of Global Regulatory Submission Department in devising strategy and team formation for Slim and Register document management system consolidation to ensure migrating documents metadata will be properly indexed. First Doc and Register super user. From January 2013 to August 2014 (1 year 8 months) Associate Regulatory Affairs Manager @ Prepare NDA and IND Annual Reports for products across therapeutic areas. This includes authoring regulatory sections, gathering all pertinent information from responsible contributors, reviewing contributions i.e., Clinical, Preclinical, and Chemical Manufacturing Controls (CMC). Prepare and sign Cover Letter, 356h, 1571, 1572, 2252 and 3674. Troubleshoot issues that arise. Scheduled and prepared all CMC/Labeling supplements for mature CV From January 2010 to January 2013 (3 years 1 month) Administrative Coordinator @ Lead cross functional teams during comment resolution meetings.; Arranged logistics for Seroquel MDD/GAD and Seroquel XR Pediatric Advisory Committee Meetings. Both meetings were within six months of each other. Completed two perceptorships within the AZ organization submitting regulatory submissions. First point of contact for alliance partner’s marketing pieces. The promotional pieces were sent directly to me. I then entered the piece into the promotional system and started the review process. Prepared Annual Reports for NDA, IND and Orphan Drug Designation for most Azenity Products, which included RITA, GI, CV, CNS, and Pain products. This includes authoring Regulatory Sections, gathering all pertinent information from responsible contributors, reviewing other contributions i.e., clinical, preclinical, and CMC. Prepare and sign Cover Letter, 356h, 2252 and 3674. Troubleshoot issues that arise. Arranged all logistics for internal meetings and external FDA meetings including Advisory Board and Type C Meetings. From January 2000 to January 2010 (10 years 1 month) Bachelor's degree, Business Administration and Management, General @ Wilmington University From 2006 to 2008 Bachelor of Science (B.S.), Organizational Management, 3.93 @ Wilmington University, DE From 2006 to 2008 Traci Williams is skilled in: Regulatory Affairs, FDA, Regulatory Submissions, Regulatory Requirements, IND, NDA, Clinical Research, Strategy, Therapeutic Areas, Project Management, GLP, Pharmaceutical Industry, Drug Development, Clinical Trials, SOP, Cross-functional Team Leadership


Traci Williams’s Personal Email Address, Business Email, and Phone Number

are curated by ContactOut on this page.

10x your recruitment & sales conversations

Contact over 200M professionals
instantly by email or phone. Reveal
personal & work email addresses, as
well as phone numbers accurately with
our ContactOut Chrome extension.

In a nutshell

Traci Williams's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

4 year(s), 11 month(s)

Traci Williams's Willingness to Change Jobs

Unlikely

Likely

Open to opportunity?

There's 88% chance that Traci Williams is seeking for new opportunities

Engage candidates 10x faster

Enjoy unlimited access and discover candidates outside of LinkedIn

Trusted by 400K users from

76% of Fortune 500 companies

Microsoft Nestle PWC JP Morgan Merck Rackspace WarnerMedia Randstad Yelp Google

The most accurate data ever

CCPA Compliant
GDPA Aligned
150M Personal Emails
300M Work Emails
50M Direct Dials
200M Professional Profiles
30M Company Profiles

Hire Anyone, Anywhere
with ContactOut today

Making remote or global hires? We can help.

  • 50 contacts/month
  • Works on standard LinkedIn only
  • Work emails, personal emails, mobile numbers
* 1 user per company limit

No credit card required

Try ContactOut for Free