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17 days old

Regulatory Compliance Specialist

Kelly Services
Indianapolis, IN 46202
  • Jobs Rated
    23rd
The Quality & Regulatory Senior Associate (QRA) will be a key driver in reviewing technical documents for cGMP compliance and will provide support to the Directory of Quality and Regulatory in areas including manufacturing compliance, human research study compliance, and state regulatory compliance matters.


**Job Responsibilities Include:**


Maintaining and organizing the documentation library


Review of documentation for drug product batches


Review and submission of marketing materials for compliance with the Office of Prescription Drugs Promotion regulations


Processing of state license renewals


Preparation for regulatory interactions


Conducting internal and external compliance audits


Representing Regulatory Affairs on project teams and providing regulatory guidance


Clearly and convincingly communicating complex issues


+ Sharing expert knowledge of complex issues

+ Reviewing technical documents for cGMP and regulatory compliance

+ Serving as an expert in technical areas in dealing with contract manufacturing organizations in the US

+ Assisting with and/or preparing high-quality submissions to the Food and Drug Administration (NDAs, Supplements, Amendments, and Annual Reports)

+ Assisting with the Quality System

+ Communicating importance of quality assurance throughout the organization and with vendors

+ Keeping up to date on regulatory requirements including monitoring FDA and other agencies regulations and standards

+ Developing regulatory strategy for difficult issues which could significantly impact project timelines and costs

+ Providing regulatory decisions with regard to acceptability of submission documents and decisions

+ Assisting with the and/or filing of applications in accordance with predetermined timelines

+ Other duties as assigned.


**Qualifications/Skills/Requirements:**


+ At minimum, a bachelors degree in a scientific discipline and 5 years of experience in pharmaceutical Regulatory Affairs

+ Experience in preparing and filing IND, NDAs, Supplements, Amendments and Annual Reports to FDA

+ Thorough understanding of the CFR, FDA/ICH guidelines and CGMPs, as they pertain to pharmaceuticals


Competitive Salary and Benefits


Career pathway to Director level


Collaborative environment


Compliance focused position


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Categories

Jobs Rated Reports for Compliance Officer

Posted: 2021-10-04 Expires: 2021-11-04

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Regulatory Compliance Specialist

Kelly Services
Indianapolis, IN 46202

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Compliance Officer
23rd2019 - Compliance Officer
Overall Rating: 23/199
Median Salary: $67,870

Work Environment
Very Good
22/220
Stress
Very Low
2/220
Growth
Poor
176/220
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