Global Labeling Lead (Groton, CT) Job in Groton, Connecticut US
Global Labeling Lead (Groton, CT)
Regulatory Affairs Project Coordinator Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a 12 month contract opportunity for a Regulatory Affairs Project Coordinator in Thousand Oaks, CA . Job Summary The Regulatory Professional, under the direction of a Regional Regulatory Lead, will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Job Responsibilities (other duties may be assigned): Assist Regional Regulatory Representative to support regional regulatory activities (E.g., IMPD development and submission, advisory committee meeting preparations) Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications. Ensure compliance with submissions regulatory agencies. Coordinate QC of regulatory documentation. (E.g., briefing packages) Provide and maintain CTA/MA documentation support. (E.g., annual reports, amendments) in collaboration with Regional Regulatory Lead. Review regional component of the Global Regulatory Plan and provide input to operational deliverables. Support RRL in review of promotional materials for commercial activities. Collaborate with CRO?s/partners to support site initiation. Coordinate collection of functional documents in support of regulatory applications. As appropriate, participate in GRT to support execution of regulatory strategy. Provide primary authorship to routine regulatory correspondence. (E.g., annual reports, investigator packages) Prepare regulatory packages and cross-reference letters to support investigator initiated studies. Approve drug shipment and Investigator Initiated Studies. Complete regulatory forms to support agency communications. (E.g., Eudract, FDA form 1571) Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams. Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance. Respond to specific requests from, and communicate relevant issues to GRT. Develop Regulatory Position with teams. Actively support regulatory compliance. Support the development and execution of GRT goals. Education and experience required : Masters degree OR Bachelors degree and 2 years of directly related experience OR High School diploma and 6-8 years of directly related experience. Database management experience. Regulated industry, science academia or clinical practice experience. For immediate consideration, click the Apply Now! button, or refer a friend by clicking the E-mail this job link provided. Kelly Scientific Resources has?grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com . Kelly Services is an Equal Opportunity Employer.