| Contract Hiring on GPRM Lead at Remote, Remote, USA |
| Email: [email protected] |
| From: Deepika Dua, Stellar Consulting Solutions LLC [email protected] Reply to: [email protected] Hi My name is Deepika & I am a recruiter at Stellar Consulting, and I came across your profile while looking for qualified candidates for GPRM Lead role. I was impressed by your experience and skills . I think you would be a great fit for this role, as you have almost all the skills & experience required for the role. Below are the job details for your reference. Job Title : GPRM Lead Duration : Long Term Job description: The Sr GPRM works under limited supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s). The Sr GPRM may act as the RA program lead on programs of limited complexity. The Sr GPRM is a member of the RA sub team and may lead or represent RA in regional or crossfunctional teams. The Sr GPRM may act as subject matter expert and/or assume mentoring role. Responsibilities Regulatory Strategy Provides input to global program regulatory strategy, including regulatory designations & innovative approaches May provide global RA leadership for specific part of the program e.g. new indication, new formulation or act as RA program lead for program of limited complexity Coordinates regulatory readiness with other line functions, Country Organizations & Regions Represents RA or leads in regional RA or cross-functional activities Provides strategic input to cross functional deliverables (e.g. protocols, IB, safety reports etc) Contributes to the development and maintenance of the Core Data Sheet (CDS) Determines requirements and coordinates activities for Health Authority (HA) interactions. May lead HAs meetings together with RA program lead. May serve as local HA liaison (e.g., FDA or EMA). Leads planning, preparation and submission of clinical trials. Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations. Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents Contributes to preparation, review and maintenance of local product information in their assigned region Leads regulatory activities during HA reviews including response to questions and HA interactions Deepika Dua Sr. Technical Recruiter at Stellar Consulting Solutions, LLC Phone : +1 678-935-7075 : [email protected] : https://www.linkedin.com/in/deepika-dua-018459166/ Keywords: access management Contract Hiring on GPRM Lead [email protected] |
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| Fri Jul 12 17:44:00 UTC 2024 |