|
Apply online for the
Regulatory Affairs Manager
position and advance your career in the
Pharmaceutical industry today.
|
Regulatory Affairs Manager : GlaxoSmithKline
|
| Job Number |
58213 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Parsippany
New-Jersey
|
| Salary (year) |
|
| Experience |
2 to 5 Years |
| Start Date |
2/19/2010 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
|
GlaxoSmithKline
View all jobs from MedImmune |
|
|
|
| Apply Online |
| What Does Your Boss Say About You? |
| Description |
Basic Qualification
BS/BA degree in science field.
A minimum of 5 years experience in the pharmaceutical industry (2- 3 yrs in Regulatory Affairs).
Good written and verbal communication skills.
Demonstrated ability to organize and prioritize assignments and meet timelines.
Highly flexible and adaptable to changing priorities. Awareness and ability to work within areas of cultural differences.
Knowledge and ability to use IT software technology.
Details
Provide operational and strategic support for Regulatory Affairs Teams. Responsible for regulatory support of products in various OTC categories such as Analgesics, Oral Healthcare, Cough/Cold, Dermatologics, Antacids, Laxatives, Dietary Supplements.
Interact and collaborate with the multi-disciplinary teams to implement development, registration, and marketing strategies for assigned marketed products and projects.
Coordinate the preparation and submission of regulatory filings (IND, NDA, 510K, etc)
Critically review internal and external submission documents. Act as central RA coordinator for local RA functions
Collaborate with functional areas to support prompt and effective preparation of global submissions to regulatory agencies.
Participate on project teams as required
Perform regulatory review of labeling, claims and advertising, change controls for specific products/projects. |
|
| Requirements |
Preferred Qualification
Working knowledge of CTD format is a plus.
At least 3 -4 years experience in Regulatory Affairs.
Regulatory experience with OTC drugs (Monograph and NDA).
Experience with cosmetics, medical devices, and dietary supplements is a plus.
Project management experience is preferred |
|
| Contact Info |
|
|
|
Apply online at company website |
|
Find More Pharmaceutical Jobs in the Pharmaceutical industry.
|
|