Advertise
|
Tell a Friend
|
About
|
Contact Us
|
Home
Find Jobs
Post Resume
Company Profiles
Career Resources
Vendors
Employers & Recruiters
Home
>> View Job
Career Tools
Get a Job Winning Resume
What's Your Former Boss Say About You?
Blast Your Resume
Free Magazines
Find Job Fairs
My Network
Find Training Courses
Pharma Talk Blog
Find Service Providers
Featured Jobs
Biotech Jobs
Associate Director, Contract Operations
MedImmune, LLC.
Medical-Device Jobs
Prin Project Engineer
Medtronic
Healthcare Jobs
Apply online for the Manager, Clinical Regulatory Affairs, USRA Vaccines position and advance your career in the Pharmaceutical industry today.
Manager, Clinical Regulatory Affairs, USRA Vaccines : GlaxoSmithKline
Job Number
57408
Employee Type
Full Time
Company Name
GlaxoSmithKline
Location
King of Prussia
Pennsylvania
Salary (year)
Experience
2 to 5 Years
Start Date
1/14/2010
Industry
Pharmaceutical
Job Type
Regulatory-Affairs
Relocation
Not Required
View all jobs from GlaxoSmithKline
Apply Online
What Does Your Boss Say About You?
Description
Basic Qualification
Relevant scientific background
Demonstrated organizational skills and written and oral communication skills
At least 5 years relevant experience in Pharmaceutical development
Ability to strategize, problem solve and influence in matrix team setting; experience in problem solving in cross-functional teams in drug/vaccine development
Scientific and regulatory knowledge pertinent to clinical development aspects RA
Operational knowledge of IND and BLA regulations pertinent to clinical product development
Experience interacting with major regulatory Agencies
Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent
Details
This position has responsibility for managing the Clinical Regulatory function by facilitating the development of strategy, policy and processes for multiple products within a Therapeutic Area of a product Franchise in the USA, including managing clinical regulatory aspects of US filing strategies for IND, BLA and supplements for assigned projects and liaison with FDA reviewer level staff. Knowledge of the corresponding CMC Regulatory role is preferred.
Requirements
Preferred Qualification
Significant experience in Vaccine/Biologic Clinical aspects of Regulatory Affairs or development:
• Experience in providing strategic advice on integrated clinical development plans for vaccines/biologics
• Experience in US regulations (IND and BLA) pertinent to vaccine development
• Experience in liaison with FDA
• Significant presence in/contributions to external organizations pertaining to regulation of vaccines/biologicals
Interest/experience in cross-training in CMC aspects of RA is desirable
Advanced degree in science desirable
Contact Info
Apply online at company website
Find More
Pharmaceutical Jobs
in the Pharmaceutical industry.