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26 days old

Remote CMC Regulatory Specialist

Kelly Services
Indianapolis, IN 46202
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Remote** **CMC Regulatory Specialist** at a prestigious Fortune 500 company in.


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.


**Job Title:** **CMC Regulatory Specialist**


**Pay: $25 per hour**


**Position Summary**

The CMC (Chemistry, Manufacturing, and Controls) Regulatory Specialist has the responsibility to support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. This includes supporting the registrations of products sourced from the US and/or contributing manufacturing sites, for both the company and contract manufacturing sites, to the global marketing affiliates. In this role, the Specialist works closely with Indianapolis regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. The Specialist works closely with Indianapolis regulatory product representatives providing essential CMC commitment information and approval status in global markets as part of manufacturing change control evaluation/completion. The Specialist appropriately updates impacted regulatory documents as part of the change control process. Key customers include the Regulatory representatives, Indianapolis manufacturing sites and the CMC Regional Centers. The Regulatory Specialist is expected to provide leadership and business process knowledge to these customers along with organization skills and prioritization ability to identify, initiate and maintain global product CMC commitments for marketed products.


**Requirements** :


Demonstrated knowledge of post-approval Chemistry, Manufacturing and Control (CMC), including submission planning and tracking


Proficiency in assessment of global CMC requirements


Knowledge and understanding of ICH requirements regarding CTD formatting


Proficiency in eCTD systems and format


Strong computer skills with proficiency in Microsoft Office applications


Proficiency in SharePoint


Proven ability to take initiative and identify opportunities to contribute to product and process improvements


Self-motivated individual with demonstrated ability to identify issues and solutions for a positive result


Demonstrated analytical thinking and problem-solving skills


Proven strong written and verbal communication skills


Demonstrated capability to track numerous communications and ensure timely response and completion of deliverable


Flexibility and ability to handle time pressures


Ability to prioritize workload and organize accordingly


Effective interpersonal skills; can work as part of a team


HS Diploma or equivalent required


General required skills also include multi-tasking numerous parallel projects, positive attitude and willingness to explore new solutions


**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com **.**


**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**


**Kelly Services is an Equal Opportunity Employer**


**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)
Posted: 2021-04-12 Expires: 2021-05-13

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Remote CMC Regulatory Specialist

Kelly Services
Indianapolis, IN 46202

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