Jobs in the United States

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Added 4 mins ago
WF
(USA) Human Resource Manager (Fashion, Import, Jewelry, Regional, Wm.Com Campus, Returns)
WMT Fulfillment Service
United States
- $84,000 to $126,000 USD / year
Live Better U is a Walmart-paid education benefit program for full-time and part-time associates in Walmart and Sam's Club facilities. Programs range from high school completion to…
Added 4 mins ago
WS
(USA) Asset Protection Operations Coach
Wal-Mart Stores Texas, LL
TX
- $65,000 to $100,000 USD / year
…associates assigning duties settingclear expectations providing associate recognition communicating expectations consistently and effectively ensuring awareness and recruiting and…
Added 17 mins ago
Senior Business Solutions Analyst - CLO
UMB Bank
Jefferson City, MO
+ Demonstrates ability to provide positive client experience through a variety of methods including associate engagement, technology, workflows, and processing
Added 24 mins ago
Investment Support Analyst-2
Nationwide Life and Annuity Insurance Co
OH
…required when new products and services are implemented. If an associate fails or is unable to acquire required licenses/registrations within the designated time period, the associate will…
Added 24 mins ago
Regional Wholesaler (RVP) - LTC and CareMatters
Nationwide Life and Annuity Insurance Co
TX
…required Federal and/or state licenses/registrations within the time period designated by the business unit. Additional licenses/registrations may be required when new products and services…
Added 32 mins ago
Pathology Laboratory Assistant
Adventist Midwest Management Services
United States
Joining UChicago Medicine AdventHealth is about being part of something bigger. It’s about belonging to a community that believes in the wholeness of each person, and serves to uplift…
Added 37 mins ago
W
Vision Center Manager - Homewood, AL
Walmart
Homewood, AL
- $24.5 to $37.5 USD / hour
…corrective actions. Directs eyewear and contact lens order processing, trial lens inventory control, and adherence to equipment calibration and maintenance protocols under applicable…
Added 44 mins ago
SO
MEAT & POULTRY INSPECTOR TRAINEE - CIRCUIT 3-3 (LIVINGSTON CO)
State of Illinois
Springfield, IL
- $4,373 to $5,703 USD / month
…our natural resources, or support families in need, you’re part of something bigger - something that touches the lives of every person who calls Illinois…
Added 44 mins ago
SO
MEAT & POULTRY INSPECTOR TRAINEE - CIRCUIT 2-2 (GRUNDY CO.)
State of Illinois
Springfield, IL
- $4,373 to $5,703 USD / month
…our natural resources, or support families in need, you’re part of something bigger - something that touches the lives of every person who calls Illinois…
Added 44 mins ago
SO
MEAT & POULTRY INSPECTOR TRAINEE - CIRCUIT 3-2 (MCLEAN CO)
State of Illinois
Springfield, IL
- $4,373 to $5,703 USD / month
…our natural resources, or support families in need, you’re part of something bigger - something that touches the lives of every person who calls Illinois…
Added 44 mins ago
SO
MEAT & POULTRY INSPECTOR TRAINEE - CIRCUIT 4-1 (SANGAMON CO)
State of Illinois
Springfield, IL
- $4,373 to $5,703 USD / month
…our natural resources, or support families in need, you’re part of something bigger - something that touches the lives of every person who calls Illinois…
Added 44 mins ago
SO
Nurse Surveyor (Health Facilities Surveillance Nurse)
State of Illinois
Westchester, IL
- $7,423 to $10,093 USD / month
…our natural resources, or support families in need, you’re part of something bigger - something that touches the lives of every person who calls Illinois…
Added 44 mins ago
SO
Nurse Surveyor (HEALTH FACILITIES SURVEILLANCE NURSE)
State of Illinois
Champaign, IL
- $7,423 to $10,093 USD / month
…our natural resources, or support families in need, you’re part of something bigger - something that touches the lives of every person who calls Illinois…
Added 1 hour ago
Software Engineer
HM Health Solutions Inc.
Remote, United States
…The position, and team, will be involved in every aspect as part of the software application build process from idea generation, business analysis, technical design and software development…
Added 1 hour ago
B
Retail Stocking Team Supervisor - Full-Time
Burlington
Natick, MA
- $19.25 to $21.25 USD / hour
- Full-time
You will enjoy a competitive wage, flexible hours, and an associate discount. Burlington's benefits package includes medical, dental, and vision coverage including life and disability…
Added 2 hours ago
B
Retail Stocking Team Supervisor - Full-Time
Burlington
North Charleston, SC
- $16 to $18 USD / hour
- Full-time
You will enjoy a competitive wage, flexible hours, and an associate discount. Burlington's benefits package includes medical, dental, and vision coverage including life and disability…
Added 2 hours ago
Manufacturing Technician I
USA - 3390 Baxalta U.S., Inc.
GA
…simple existing procedures. You will demonstrate procedures as a part of a training session and may schedule department or process activities which could involve coworkers. You will report…
Added 2 hours ago
Associate Technical Analyst
Spirit AeroSystems
Wichita, KS
Develop, analyze, and apply material properties and design allowables, processing methods, and quality engineering specifications and standards to metallic fabrication projects.
Added 2 hours ago
Associate Advanced Research Engineer
Spirit AeroSystems
Wichita, KS
Support multi-functional teams in the above efforts, coordinate the identification and capture of cost and time savings, and assist in strategic technology planning.
Added 2 hours ago
SS
Claims Auditor
SHPCA SCAN Health Plan
Long Beach, CA
- $25.38 to $36.76 USD / hour
Ensure regulatory compliance and overall quality and efficiency by utilizing strong working knowledge of claims processing standards.
Added 2 hours ago
SU
Part Time Product Specialist
Skechers USA Retail, LLC
Gilroy, CA
- $17 USD / hour
- Part-time
As a Sales Associate, better known as a “Product Specialist,” at Skechers, you’re not just working a job - you’re joining a team where growth, customer connections, fashion, and comfort are…
Added 2 hours ago
NB
Sr. Maintenance Technician
Niagara Bottling, LLC
Rialto, CA
- $40.34 to $60.1 USD / hour
Plastic processing at high speeds while maintaining tight part tolerances and acceptable levels of acetaldehyde (AA)
Added 2 hours ago
LH
Full Time - Sales Specialist - Millwork - Day
Lowe's Home Centers, LLC
Mcminnville, OR
- Full-time
Whether you need a part-time position or a place to plant yourself and grow, Lowe's is ready to support your goals. As a Lowe's associate, you'll gain access to a variety of benefits beyond…
Added 2 hours ago
SO
DOLA - Campus Housing & Recovery Specialist - Term Limited
State of Colorado
Denver, CO
- $4,955 to $6,442 USD / month
This position assists the OHI Associate Office Director with contract management, contract monitoring, operations oversight, and program oversight for the two DOLA campuses: Sage Ridge…
Added 3 hours ago
Relationship Banker I - PT 20 hour - Richland
Regions Bank
Richland, MS
…create meaningful personal connections with customers while processing transactions, identify ways for Regions to meet customer needs, and assist in resolving end to end customer service…

Makro Scientific

Regulatory Affairs Associate

Piscataway Township, NJ, United States

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Job details

Posting language: English
Posted: Aug 24, 2016

Original job description

Company Description

Makro Scientific:

Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since 1996, MakroScientific’s proven staffing solutions have helped many Life Sciences companies succeed and visualize their goals by increasing innovation and decreasing costs while maintaining the complex service level expectations. Our global presence with offices in USA (NJ, PA, IL, CA) and offices in UK, Europe and Asia enables us to be a powerful contributor and connector of right Talent.

Job Description

Description:

The Regulatory Affairs Associate, with minimal guidance prepares, reviews and submits high quality annual reports with FDA within Annual report timelines and in accordance with regulatory guidelines and applicable federal laws.

Responsibilities:

With minimal guidance, ensure to compile and complete the Annual reports with high-quality, following the regulatory guidelines and internal processes within time lines. Coordinate with all supporting departments for obtaining documents for annual report submissions. Should archive and maintain all post approval submissions in a systematic way in RA library. Assists in Projects Assigned for Post-Approval team (PAS, CBE-30, CBE0) Assists technical services team by providing required information from the submissions as and when required. Organize and maintain submission components associated with a regulatory submission electronically. This may include scanning, converting to pdf, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress e.t.c. under superior guidance. Gain more knowledge in the use of e-CTD structures for submissions. Works with colleagues in resolving regulatory issues and/or problems Should archive and maintain all submissions in a systematic way. Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department. Maintain current knowledge of regulations and other issues that affect products and industry Maintain the regulatory databases up to date and as per the set criteria's.

Requirements:

Master Degree is Science or Technical Years of experience in Pharmaceutical Industry: 3 years or more Type of work: Regulatory Affairs or related coursework Proofreading abilities. Working knowledge and experience with 21 CFR, US FDA guidance, ICH guidelines Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Outlook and Adobe Acrobat is a must. Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. Excellent written and verbal communication skills and interpersonal skills. Ability to communicate effectively and collaboratively as part of a team in a respectful manner Ability to interface with professionals domestically and abroad. Ability to work independently, self-starter Good problem solving skills and analytical ability Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Outlook and Adobe Acrobat is a must.

Qualifications

Master Degree is Science or Technical

experience in Pharmaceutical Industry: 3 years or more

Type of work: Regulatory Affairs or related coursework

Additional Information All your information will be kept confidential according to EEO guidelines.

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More about this job

Skills

Regulatory affairs
Pharmaceutical industry
Editing
Computer skills
Microsoft Word
Microsoft Excel
Microsoft Outlook
Adobe Acrobat
Time management
Multitasking
Prioritization
Attention to detail
Communication skills
Interpersonal skills
Work independently
Problem solving

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