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18 days old

Remote Regulatory Associate CMC

Kelly Services
Indianapolis, IN 46202 Work Remotely
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** **Regulatory Associate CMC** at a prestigious Fortune 500 company.


**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:** **Remote** **Regulatory Associate CMC**


**Pay: $40 per hour**


**Position Summary**

The GRA-CMC Regulatory Associate leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing authorization submission management processes. The Regulatory Associate also partners with GRA-CMC Scientists to help create and manage submission content, and to provide guidance on structure and content placement within CTD registration submissions, and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions. The Regulatory Associate works within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working knowledge of internal procedures, guidance and regulatory precedence. The Regulatory Associate will triage and manage the communications between our Lilly Affiliates, GRA-CMC Scientists, Specialists, and the Quality/ Reg Representatives The Regulatory Associate utilizes GRA-CMC submission process expertise and their expertise with - Information Technology tools to develop project management expectations across projects. Based on implementation and supply chain needs within manufacturing, the GRA-CMC Regulatory Associate will be responsible for routine communication of submission tracking requirements to both GRA-CMC Scientists and internal customers. The scope of work includes global regulatory requirement assessment and strategy development, coordination of submissions with the submission specialists, and project management for marketed product support.


**Requirements** :


MUST REFLECT ON RESUME: 3+ years experience in a CMC/Chemistry Manufacturing and controls position (that way they have regulatory document exp) OR 3+ years Module 3 experience (regulatory app that is specific to CMC).


Microsoft Office experience.


Other requirements include: Soft skills of Project Mgmt and Project planning, seeing project from beginning to end, working with in the group, to ensure they are staying on task and able to meet deadlines, etc.


Preferences - Nice to haves include:


Pharma exp specifically. Device experience would be helpful. Combination products experience, device regulatory experience.


A good knowledge of regulatory requirements, specifically with knowledge of changes in the US or EU.


**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)

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Posted: 2021-03-29 Expires: 2021-04-29

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Remote Regulatory Associate CMC

Kelly Services
Indianapolis, IN 46202

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