Advanced Search
Title
Company
Description

Location:

Start New Search:

regulatory affairs associateesgcajerolot associatecashier retailseasonal associatecmcqa qcseasonal retailstock associateimport exportdocument controlsellersupplementsmunicipalityloweswe trainretail associatemanager in trainingstore associate

Regulatory Affairs Associate

Share Job
Polygen PharmaceuticalsEdgewood, NY
  • Regulatory Affairs Associate
  • Coordinate with other departments (Document Control, Quality Control, Quality Assurance, and Manufacturing) to obtain all the CMC documents required for ANDA, Supplements, Annual Reports and Amendments.
  • Utilize eCTD publishing and SPL software systems as well as the ESG Gateway system in accordance with regulatory submission requirements.
  • Assist the Director of RA to maintain compliance with Federal and State Regulatory Licenses including FDA, DEA and Import/Export.
  • per company objectives by working with other departments (QA, QC, R&D) in accordance with company deadlines.
  • Draft content for finished product labeling and prepare product labels with the help of outside approved vendor to ensure compliance with FDA regulations.
  • Coordinate and compile all the documents necessary for quality regulatory filings in accordance with company SOPs GMPs, GLPs and other FDA guidelines for generic and OTC drug products.
  • These filings include ANDAs, supplements (Prior Approval/CBE/Annual Reportable), responses to FDA action letters and annual reports to US FDA in eCTD format.
Expired 5 years agoInactive Job

Similar jobs:

Active
  • All Jobs
  • Active
Lot Associate
The Home DepotMargaretville, NY
Lot Associate 319269982 Middletown, Indiana, US, 47356 Lot Associates assist customers with the loading of their vehicles and also monitor and maintain the entrance of the store.Expired 5 months ago
Seasonal Retail Associate
Lowe'sMargaretville, NY
What You Will Do All Lowes associates deliver quality customer service while maintaining a store that is clean, safe, and stocked with the products our customers need.
Temporary
Expired 5 months ago
Retail Sales Associate
Cumberland FarmsHunter, NY
Job Description - Retail Sales Associate - Hunter, NY (1404259) Retail Sales Associate - Hunter, NY - 1404259 Whether you are looking for an incredible full-time career, or a great part-time job, the Customer Service Associate is the backbone of our company.Expired 5 years ago
Seasonal Retail Sales Associate
Kohls Department StoresMargaretville, NY
Job Description Creates a friendly and welcoming environment by greeting and offering assistance to customers.
Temporary
Expired 7 months ago
LEAD SALES ASSOCIATE
Dollar GeneralMargaretville, New York
The Lead Sales Associate helps maintain a clean, well-organized store with a customer-first focus.Expired 6 months ago
LEAD SALES ASSOCIATE
Dollar GeneralMargaretville, NY
The Lead Sales Associate helps maintain a clean, well-organized store with a customer-first focus.Expired 3 months ago
Store Associate
CVS HealthMargaretville, NY
The Retail Store Associate position provides an opportunity, in a leading retail setting, to excel in a growing, high impact, customer focused role, working both independently and as a member of a team, to positively impact the lives of others.Last updated 30 minutes ago
VIP Residential Associate
Opportunities for Otsego, Inc.Oneonta, NY
VIP Residential AssociateExpired 5 years ago
Associate Claims Representative
UnitedHealth GroupNew Kingston, NY
And with the incredible growth of our business, its a dream that definitely can come true when you join us as an Associate Claims Representative.Expired 4 years ago
MFG Associate I - Second Shift
MallinckrodtHobart, NY
Move blend material, culls and final product to/from cage or storage area.Expired 1 year ago
Retail Store Associate
CVSMargaretville, NY
Job Title : Retail Store Associate Job ID : 25552BR Location : NY - Margaretville Street Address : 60 Bridge St. PO Box 698 Category : Cashier Description : Job DescriptionRetail Store Associates play a meaningful role within the CVS Health family.Expired 7 months ago
Merchandise Associate - Southside Mall
JCPenneyOneonta, NY
Well being a Merchandise Associate at JCPenney might be the position for you!Expired 5 years ago
Associate Claims Representative
Optum360New Kingston, NY
And with the incredible growth of our business, its a dream that definitely can come true when you join us as an Associate Claims Representative.Expired 4 years ago
Veterinary Technician: Instructional Support Associate
SUNY DelhiDelhi, NY
Veterinary Technician: Instructional Support AssociateExpired 5 years ago
Store Associate ( Home Improvement)
Wadler Bros., Inc.Fleischmanns, NY
Full Job Description Store Associate (Home Improvement) Job Description: Wadler Bros., Inc. is a building supply store and ready-mix concrete supplier.
Full-time
Expired 1 month ago