Northrop GrummanRedondo Beach
The Program Manager 2 will be responsible for managing a subset of the F-35 Support Equipment portfolio in the acquisition of fleet support equipment in all phases of program life cycle; proposal development, negotiation, startup, execution, and completion (contract closeout).
Leading cross-function...
AbbVieIrvine, 32 mi from Los Angeles
Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent quality oversight of GxP activities, covering...
AbbVieIrvine, 32 mi from Los Angeles
Job Description
The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics...
Aequor Technologies LLCThousand Oaks, 41 mi from Los Angeles
FULLY REMOTE
The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases...
Allergan AestheticsIrvine, 32 mi from Los Angeles
Job Description
Description
The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team.
Plans...
Aditi ConsultingThousand Oaks, 41 mi from Los Angeles
Summary:
The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases...
SAICCalifornia
Technical Writer and Communications Analyst. The successful candidate will have specific, recent, and extensive experience providing life cycle support and technical writing/editing or technical system support for US Navy systems. This position will involve being responsible for creating and prepari...
Booz Allen HamiltonEl Segundo
DoD acquisition system, life-cycle planning, program management, and business operations. DoD key program milestones and decision events. Professional Development Program. Program Management Level I or higher Certification or Project Management Professional.
...
Get new jobs by email!
Get email updates for the latest Regulatory Affairs jobs in Los Angeles
It's free, and you can cancel email updates at any time
Regulatory Affairs Associate
Hawthorne (CA) | www.resume-library.com |
Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Associate for a FULL-TIME assignment with one of our premier Pharmaceutical Services clients in Westchester County, NY.
We have 2 openings, one Associate Director level and one Associate level. So if you are better suited for the Senior level role let me know. But for the Junior level position, here are the details:
Looking for someone to work on FDA labeling!
This is a direct-hire, permanent position.
Client cannot sponsor Visas now or in the future.
Do you have a Scientific background? You will be reviewing leaflets/materials.
Interviews will occur next week!
Onsite/hybrid work is required - this is not remote
Responsibilities:
Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.
Prepare and submit updated labeling in eCTD format to the FDA.
Review labeling revisions for Firm and private label products.
Initiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS).
Convert Firm labels and customer's labels to SPL.
Prepare Drug Listings for newly approved and private label products and resolve returned listing problems.
Reserve NDC numbers for Firm and customer labeling.
Monitor FDA web sites for revisions to labeling for RLD of Firm products.
Assist with customs release inquiries.
Track and advice of all labeling revisions for incorporation into annual reports.
Respond to requests for information regarding marketed prescription and OTC products.
Maintain documents on approved and newly filed products.
Electronically search for new regulatory guidelines and regulations. Perform routine monitoring of Federal Register.
Assist with review, approval, and submission of Promotional Materials for Firm Products.
Assist with projects such as FDA inspection, teleconferences arranging webinars, etc.
Collect information to assist in compiling departmental budget.
Required Skills:
Bachelor's degree.
Minimum 1-3 years regulatory experience in the generic pharmaceutical industry.
Advanced computer skills required.
Preferred Skills:
B.A. in scientific field preferred.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements.
When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work.
Please find us at .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status.
We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.
We have 2 openings, one Associate Director level and one Associate level. So if you are better suited for the Senior level role let me know. But for the Junior level position, here are the details:
Looking for someone to work on FDA labeling!
This is a direct-hire, permanent position.
Client cannot sponsor Visas now or in the future.
Do you have a Scientific background? You will be reviewing leaflets/materials.
Interviews will occur next week!
Onsite/hybrid work is required - this is not remote
Responsibilities:
Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.
Prepare and submit updated labeling in eCTD format to the FDA.
Review labeling revisions for Firm and private label products.
Initiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS).
Convert Firm labels and customer's labels to SPL.
Prepare Drug Listings for newly approved and private label products and resolve returned listing problems.
Reserve NDC numbers for Firm and customer labeling.
Monitor FDA web sites for revisions to labeling for RLD of Firm products.
Assist with customs release inquiries.
Track and advice of all labeling revisions for incorporation into annual reports.
Respond to requests for information regarding marketed prescription and OTC products.
Maintain documents on approved and newly filed products.
Electronically search for new regulatory guidelines and regulations. Perform routine monitoring of Federal Register.
Assist with review, approval, and submission of Promotional Materials for Firm Products.
Assist with projects such as FDA inspection, teleconferences arranging webinars, etc.
Collect information to assist in compiling departmental budget.
Required Skills:
Bachelor's degree.
Minimum 1-3 years regulatory experience in the generic pharmaceutical industry.
Advanced computer skills required.
Preferred Skills:
B.A. in scientific field preferred.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements.
When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work.
Please find us at .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status.
We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.
Best jobs you don't want to miss: