Image of Linda Kramer

Linda Kramer

Associate Director Regulatory Affairs @ GSK

Regulatory Affairs CMC Lead at Spark Therapeutics, Inc.

Greater Philadelphia Area

Ranked #1,013 out of 20,260 for Associate Director Regulatory Affairs in United States

Section title

Linda Kramer's Email Addresses & Phone Numbers

Linda Kramer's Work Experience

GSK

Associate Director Regulatory Affairs

December 2005 to April 2014

King of Prussia

Centocor

Sr QA Compliance Associate

January 2005 to December 2005

Malvern, PA

The Immune Response Corporation

QA Supervisor

January 2000 to November 2002

King Of Prussia , PA

Linda Kramer's Education

Temple University

Master's degree, Quality Assurance/ Regulatory Affairs

Cedar Crest College

Bachelor's Degree, Chemistry, Graduated

1983 to 1987

Linda Kramer's Professional Skills Radar Chart

Based on our findings, Linda Kramer is ...

Conscientious
Visionary
Engaging

What's on Linda Kramer's mind?

Based on our findings, Linda Kramer is ...

50% Left Brained
50% Right Brained

Linda Kramer's Estimated Salary Range

About Linda Kramer's Current Company

GSK

Responsible for submitting and communicating new vaccine product licensure and post-approval CMC/facility changes to the FDA for international biological vaccine sites. Discussions with Regulatory Authorities, including Type C meetings and GMP site inspections.Management of Global Regulatory Cross Product Team for post approval submissions worldwide.

Frequently Asked Questions about Linda Kramer

What company does Linda Kramer work for?

Linda Kramer works for GSK


What is Linda Kramer's role at GSK?

Linda Kramer is Associate Director Regulatory Affairs


What is Linda Kramer's personal email address?

Linda Kramer's personal email address is li****[email protected]


What is Linda Kramer's business email address?

Linda Kramer's business email address is l****[email protected]


What is Linda Kramer's Phone Number?

Linda Kramer's phone (**) *** *** 281


What industry does Linda Kramer work in?

Linda Kramer works in the Pharmaceuticals industry.


About Linda Kramer

📖 Summary

Associate Director Regulatory Affairs @ GSK Responsible for submitting and communicating new vaccine product licensure and post-approval CMC/facility changes to the FDA for international biological vaccine sites. Discussions with Regulatory Authorities, including Type C meetings and GMP site inspections.Management of Global Regulatory Cross Product Team for post approval submissions worldwide. From December 2005 to April 2014 (8 years 5 months) King of PrussiaSr QA Compliance Associate @ Centocor Responsible for inspection readiness for Regulatory Authorities.Responsible for performing internal quality audits of the monoclonial antibody manufacturing facility and maintaining a state of compliance of the quality systems for GMP inspections. From January 2005 to December 2005 (1 year) Malvern, PAQA Supervisor @ The Immune Response Corporation Responsible for the Materials Compliance Department for a phase III HIV-1 immunotherapeutic compound. Supervised two specialist level personnel. Performed both domestic and international GMP audits of Raw Material, subcontractor laboratory testing, and subcontractor packaging suppliers. Performed internal quality audits of the manufacturing facility. From January 2000 to November 2002 (2 years 11 months) King Of Prussia , PACMC Regulatory Lead Spark Therapeutics @ Spark Therapeutics, Inc. Philadelphia, Pennsylvania, United StatesDirector Global Regulatory Affairs @ GSK Responsible for management and leading of gloabl team for submitting and communicating new vaccine product licensure and post-approval CMC/facility changes to the FDA, EMA, International health authorities for international biological vaccine sites. Lead several Type C meetings and discussions with FDA and review of scientific advice documents for EMA. From April 2014 to June 2020 (6 years 3 months) King of PrussiaSr Process Scientist @ Centocor Responsible for resolving technical manufacturing nonconformances utilizing both cGMP compliance knowledge and CMC technical processing knowledge. Responsible for CMC process optimization teams and submitting compliance and required regulatory documentation such as CBE-30’s for CMC process improvements and changes. From November 2002 to January 2005 (2 years 3 months) Malvern, PAQA Supervisor @ Tektagen Inc Responsible for the calibrations and validation of laboratory equipment utilized in the assay testing at a contract biological testing laboratory. Assisted the Sr. QA Manager with internal quality operations of the company in support of client quality and regulatory (FDA) audits. Performed GMP/ GLP vendor and subcontractor audits. Inspected and audited lab studies for GMP/GLP compliance.Supervised two technician level personnel. From September 1997 to December 1999 (2 years 4 months) Malvern, PA


Linda Kramer’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

Linda Kramer's Personality Type

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

Average Tenure

3 year(s), 10 month(s)

Linda Kramer's Willingness to Change Jobs

Unlikely

Likely

Open to opportunity?

There's 100% chance that Linda Kramer is seeking for new opportunities

Linda Kramer's Social Media Links

/school/te... /company/s...
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