Job Description

As one of the world’s preeminent consultancies, NNIT has served the Life Science industry for more than twenty years. A global leader in the industry, NNIT is at the forefront of the latest advances in technology – including IoT, AI, Virtual Reality, Augmented Reality, and Data Analytics – to streamline Quality Assurance, Regulatory Affairs, Clinical, Pharma Production, and Laboratory processes for our clients. Over the last four years, NNIT has experienced unprecedented growth, including our US Operations, adding more than 1,000 team members worldwide as we continue to grow with quality and speed.

We are currently seeking a Regulatory Operations Support Consultant wtih Veeva RIM experience to join our team.   

In this role - you will be performing Regulatory and Technical Support to:

• Manage process development and optimization for submissions management
• Enter and manage regulatory information in the authoritative system
• Function as a process expert for submission management and archival in the RIM system
• Create reports/metrics to identify issues and analyze data trends
• Run data quality reports to check process compliance and escalate issues when necessary
• Monitor data quality andaccuracy
• Ensure data is available in a complete, and timely manner
• Identify system and process gaps in regulatory operations, including submission management, publishing, registrations, and archive
• Develop and maintain RIM reports and dashboards
• Provide support for internal audits and HA inspections
• Execute operational tasks according to RIM procedures and work instructions
• Participate in system testing for upgrades by executing scripts and validation
• Provide advisory support for prioritization of system upgrades
• Manage system administration activities and issue resolution

The RIM BA Reg Ops Support position is responsible for working with the business functional teams across Regulatory to define requirements and deliver software-based solutions including reports, customizations, querying data for business decisions, and ongoing system administration tasks.

The role requires:

• Bachelor’s Degree (Information Systems of Life Sciences preferable)
• Minimum of 3 to 5 years of experience of experience in Pharmaceutical, Biotechnology, or Life Sciences, with a specific focus in Regulatory and working knowledge of Biopharma drug development and approval process
• 3+ years’ experience in Regulatory Information Management (RIM), Regulatory EDMS capabilities, or operations in a similar capability model in GxP/Regulated Systems
• Working knowledge of applicable Regulatory Agency regulations, guidelines, and specifications (e.g., FDA/EMA, ICH, eCTD, IDMP) and industry best practices pertaining to Regulatory Processes & Systems
• Regulatory operations experience; submissions publishing a plus
• Familiarity with MDM & enterprise reporting capabilities a plus (e.g., Tableau, etc.)
• Experience with Veeva Submissions and Archives a must

The RIM Business Analyst – Regulatory Operations Support Consultant must be able to apply good judgment on what level of detail makes sense for the situation and cannot be dogmatic in adhering to a process or procedure when the results defy commonsense.

The main skills of the person include:  

• Knowledgeable in Veeva RIM applications and educated/trained in the Regulatory drug approval process for operations
• Awareness of the procedures and decision-making process of government Health Authorities and how it relates to RIM
• Strong understanding of regulatory operations
• Knowledge of computer systems in an R&D environment. Firm knowledge and experience with eCTD, SPL and submission standards. Ability to navigate marketing application submissions’ structure and content. Basic understanding of electronic records management rules
• Practical experience with desktop application software suites
• Effective critical thinking and communication skills
• Excellent organizational skills and a hands-on approach
• Ability to work with key business stakeholders across multi-disciplinary teams
• Independent, organized, and able to multi-task in project environments
• Team player who embraces a culture rooted in collaboration that enables a collective decision-making process

NNIT has a unique culture and approach to business that is quickly making us an employer of choice in the US. We are open, honest, and value-adding in everything we do. Whether it is our weekly Friday meetings for all US employees or our annual company-wide Kick-Off meetings, NNIT encourages employees to lean in and participate in creating new ideas and developing best practices. We want to grow our people through training and certification opportunities and provide them with “stretch assignment” opportunities to gain experience in new areas. At NNIT, we strive to have a good work-life balance for all of our employees and support a remote working model with travel only as needed; however, there may be times when projects require working at client sites to maximize NNIT’s value.