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19 days old

Regulatory Affairs Coordinator

Kelly Services
Bridgewater, NJ 08807
**Regulatory Coordinator**


Kelly has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent opportunity for a Regulatory Affairs Coordinator our client, a leader in the pharma industry, located in **Bridgewater, NJ.**


**Two days remote/Three days on site**


**14 month assignment**


**OBJECTIVES**


+ Provide Information and Regulatory Support to International RA team members for Product Registrations, Renewals, Launches, etc.

+ To provide support and needed information to all global regions on all US products across the clients and subsidiaries product portfolio so that regions can file products with the needed documentation and information for their submissions.


**RESPONSIBILITIES**


+ Responsible for providing Regulatory Affairs support to International RA teams for product registrations, renewals to global markets for all US approved/cleared products including pharmaceuticals, medical devices, nutritional and skin care products.

+ The incumbent will provide support for all requested documents (certificates/letters), search and retrieve product labeling & all needed support documentation.

+ Internal R&D and Business functional groups to support R&D Development projects as well as expand already approved products throughout the clients regions.

+ Regional functional groups (mainly Regulatory)

+ External contract manufacturing organizations (CMO) and partners

+ With the oversight of Regulatory leadership, the incumbent will prepare and obtain:

+ Letter of Authorizations/Letter of Declaration/Power of Attorney Letters

+ Certificate of Free Sale from State of NJ/ CPP from Federal Agency ( FDA)

+ Notarized, Legalized, or Apostilled Regulatory Documents


**Will also be working on:**


+ Technical Inquiries and coordination (including Manufacturing, process, raw materials, technical files)

+ Search and retrieve documents from RA system and tools and provide links to the international requestors (SharePoint, Clinops, Liquent /Insight viewer) where information can be found.

+ Work with other International Support groups (Operations, QA, etc.) to provide assistance to regions.


**QUALIFICATIONS**


+ BS in Biological Sciences preferred

+ 3-5 years of Experience in Regulatory Affairs (preferably on Global programs)

+ **Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.


**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: 2021-09-03 Expires: 2021-10-21

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Regulatory Affairs Coordinator

Kelly Services
Bridgewater, NJ 08807

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