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Mgr, Reg Affairs

IQVIA Rockville, MD Full-Time
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Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Regulatory Manager/Project Manager


Minimum Qualifications Summary:
• Bachelor’s degree in a Health or Science field. MS is preferred. PM formal training is preferred. 
• Minimum 7 years of biotechnology/pharmaceutical industry experience working in regulated environment. 
• 1 or more years in a Project Management role or equivalent.
• 6 or more years working in a Regulatory role including assisting in the developing regulatory submission documents and coordinating delivery to submission plans.
Patient Safety/Pharmacovigilance experience is highly preferred.
• Experience in regulatory requirements for asset transfers is highly preferred.
• Knowledgeable in worldwide RA and PV Regulations, ICH guidance 


Main Responsibilities:
• Lead and manage regulatory activities related to asset transfers following established organizational processes and procedures. 
• Manage regulatory projects planning, execution, and monitor & control efforts, report on progress, manage project closing as required. 
• Work with project leadership, team and other stakeholders preparing project plans and associated agreements.
• Organize, attend and facilitate cross-functional and regulatory meetings as needed.
• Coordinate tracking and delivery of the project strategic plans including preparation of regulatory submissions, provide status updates as required. 
• Lead and/or assist in Regulatory Risk management efforts for the assigned projects.
• Ensure collaborative relationship with the assigned project internal and external stakeholders.
• Responsible for timely and seamless delivery of the assigned work. 
• Assist with location of documents, ad hoc requests or communication of the project plan.
• If assigned, lead a broad cross-functional teams.
• If assigned, act as the Patient Safety and Regulatory Affairs lead in the cross-functional teams


Skills required:
• Highly organized, proactive and detail oriented
• Skilled communicator and facilitator
• Effective time manager
• Proficiency in standard business productivity tools (e.g. Microsoft Office package)
• Strong understanding of regulatory and patient safety documentation, and GDP
• Knowledge/experience in systems for document storage and retrieval
• Strong team building capabilities
• Good organization and problem-solving skills
• Ability to establish and maintain effective working relationships with co-workers, managers and clients

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at URL blocked - click to apply to arrange for such an accommodation.



Job ID: R1065705
 

Skills required

Pharmaceuticals
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Job ID: R1065705

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IQVIA (NYSE:IQV) is a leading global provider of information, innovative technology solutions and contract research services dedicated to using analytics and science to help healthcare stakeholders find better solutions for their patients. Solutions are powered by the IQVIA CORE, which combines big data, advanced technology, analytics and extensive industry knowledge. Formed through the merger of IMS Healthcare and Quintiles, IQVIA has approximately 55,000 employees worldwide.

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