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Mgr, Reg Affairs (R1064795) in Kochi, India at IQVIA™

Date Posted: 6/7/2019

Job Snapshot

  • Employee Type:
  • Location:
    Kochi, India
  • Date Posted:
  • Job ID:

Job Description

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.

Job profile: Manager - Maintenance

Technical Skills/Experience
• Degree in life science-related discipline or professional equivalent
• Minimum of 6 years in international regulatory lifecycle maintenance experience, focusing on marketed products
• Experience in regulatory procedures in Europe and/or emerging markets (e.g. variations/renewals/aggregate reports) to support lifecycle maintenance activities
• Experience in new MAA applications in Europe and/or emerging markets
• Good understanding of pharmacovigilance activities relevant to marketed products
• Experience in managing regulatory projects
• Experience in line management
• Interaction with Regulatory Agencies (EU/EMA)
• Involvement in regulatory strategy and determination of documentation requirements, timelines, budgets
• Preparation of relevant CTD documents to support submissions (mainly Module 1), in collaboration with technical/CMC/Labelling experts
• Experience in quality review of technical/ regulatory documents
• Able to mentor junior colleagues and to assist in their training and development as appropriate
• Able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate

Soft Skills
• Excellent verbal and written communication skills in English are essential, including the ability to deliver difficult messages in an appropriate way to client / stakeholders
• Be able to manage peaks of workload and prioritise workload with minimal supervision
• Ability to work to tight timelines
• Open and communicative personality
• Good team player
• Good negotiating skills
• Be able to identify and resolve issues, using flexible adaptable approach
• Strong computer skills, including MS Office applications, data and document management systems
• Adaptable to change
• Cultural awareness

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™

Job ID: R1064795