IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
PURPOSE
Prepares and/or reviews regulatory submissions to support marketing authorisation activities for either internal and/or external clients. With guidance from senior staff, provides regulatory support for more complex projects.
RESPONSIBILITIES
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
- Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.
- Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate.
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
- May present to clients on complex regulatory processes at large full service bid defence meetings by phone or in person.
- May act as reviewer for regulatory SOPs, as assigned and appropriate.
- May prepare and deliver regulatory training to IQVIA small groups or individuals.
- Performs other tasks or assignments, as delegated by Regulatory management.
TECHNICAL SKILLS/EXPERIENCE
- Degree in life science-related discipline or professional equivalent
- Minimum of 3 years in regulatory lifecycle maintenance experience, focusing on marketed products
- Experience in regulatory procedures in Europe and/or emerging markets (e.g. variations/renewals/aggregate reports). Experience in new MAA applications in Europe and/or emerging markets an advantage
- Experience in marketing authorization transfers - essential
- Experience in food supplements registration - nice to have
- Good understanding of pharmacovigilance activities relevant to marketed products - nice to have
- Possibly has experience in managing regulatory projects
- Interaction with Regulatory Agencies (EU/EMA)
- Possibly has experience of 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 assist in review and revision of regulatory SOPs / act as reviewer as appropriate
SOFT SKILLS
- Excellent verbal and written communication skills in English and Russian are essential
- Well organised
- Be able to manage peaks of workload and prioritise workload with some supervision
- Ability to work to tight timelines
- Open and communicative personality
- Good team player
- Good negotiating skills
- Ability to identify issues and contribute to their resolution
- Strong computer skills, including MS Office applications, data and document management systems
- Adaptable to change
- Cultural awareness
Join Us
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
