| Remote Contract Hiring on RA Coordinator 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 RA Coordinator 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 : RA Coordinator Location : Remote Duration : Long Term Job description: The RA coordinator works under limited supervision of the regulatory affairs (RA) program led to develop and implement the global regulatory strategy for program(s) through development, registration, and post approval in the assigned region(s). The Coordinator may act as the RA program lead on programs of limited complexity. He is a member of the RA sub team and may lead or represent RA in regional or cross functional teams. The Coordinator 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 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). Regulatory Submissions : Contributes to preparation, review, and maintenance of local product information in their assigned region Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions. Maintains regulatory information in compliance databases and document management systems. May serve as RA subject matter expert . May assume mentoring role Life cycle management Maintenance: preparation of selected global regulatory submissions (eg Annual, aggregate safety reports, renewals, variations, etc.) for assigned portfolio. Portfolio Transformation: portfolio streamlining activities eg. pruning and deregistration, divestment/integration, RxGx, portfolio transformation and manufacturing production transfer as applicable. Business & Operational Excellence: Procurement of key components e.g. registration samples, certificates of pharmaceutical product CPPs, etc.in support to regional. Regulatory submissions For LCM Sr RA Coordinator acting as Management of several direct reports, including talent recruitment, performance management and development of associates Experience: 4 years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region. Experience in leading cross-functional teams. Strong collaboration, communication influencing and problem-solving skills. Organizational awareness (e.g., interrelationship of departments, business priorities). C compliance and Quality mindset 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: cprogramm access management Remote Contract Hiring on RA Coordinator [email protected] |
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| Fri Jul 12 21:47:00 UTC 2024 |