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Global Regulatory Manager

Company: TSR Consulting Services, Inc.
Location: Trenton
Posted on: November 20, 2020

Job Description:

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical company is hiring a Global Regulatory Manager on a contracting basis. Work Location Princeton NJ Summary Responsible for driving regulatory processes in line with businessRD objectives to ensure timely registration of new productsline extensions and variation applications Responsible for interactions with Country Regulatory managersregional leads regarding product registrations Drives and support local projects and department related assignments Responsible to keep up to date with the regulatory environment within the industry Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases Responsible for overall regulatory related topics for assigned products therapeutic area Coordinate internal alignment and approval of global submission plans ensure those plans can be executed with internal and external resources on time Manage, track, review regulatory deliverables from external partners in line with vendor manager Interface between Global and Local, the GRM lead International Regulatory Teams engage the local GRS regulatory teams, communicate Project specific information (follow-up, update) to local teams, ensure alignment between registrationsubmission requirements and development plans, translate global regulatory expectations into local plans and lead the execution of these plans, digest and communicate Global Regulatory plans, including HA engagement plans to countries, digest and communicate results for key clinical trials, obtain aligned regulatory position, Represent and deliver the Global TA position, track the execution of the global submission plan. Required Skills Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary) 2-4 years of relevant experience expected , especially in Intercontinental region Demonstrated ability to break down complex, scientific content into logical components Demonstrated ability to facilitate issue resolution Demonstrated ability to organize prioritize tasks Understanding of tactical role of GRS in the drug development process Understanding of general global regulatory requirements for drugs in development Understanding of PDC process and specific GRS responsibilities deliverables at PDC Decision Points for International Please contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested. Regards, Dianne Weiss Technical Recruiter 646-668-4249

Keywords: TSR Consulting Services, Inc., Trenton , Global Regulatory Manager, Other , Trenton, New Jersey

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