Global Regulatory Manager
3551 Lawrenceville Road Trenton, NJ 08648 US
Target Pay Rate: 50-88.66/hr **salary will be commensurate with experience
- Interact with regulatory liaisons, global regulatory managers, and International Strategy leads (ISLs) to ensure that the registration status is up-to-date and accurate in all countries that market BMS products.
- Resolve contacts with end-users within the expected time frames or escalate appropriately.
- Proactively seize opportunities to improve user effectiveness. Communicate potential service level issues to management. Communicate effectively with internal customers.
- Create and monitor workflows that progress regulatory objectives and activities.
- Expand knowledge and skills to develop expertise across all areas of system functionality.
- Function as a super user with at least 3-6 of the following regulatory processes enabled in the RIM system:
- Submissions and approvals for marketed and investigational products
- Accuracy of licensing and product specific details
- Global labeling /core data sheet updates, distribution and tracking through country-level implementation of changes
- Ensure information is logged for health authority (HA) interaction, correspondence and commitments
- Manage the creation and QC of all HA queries and interactions with SMEs
- Support other regulatory processes when needed including the Global Submission Plan, Risk Management Plan and Submission Content Plan
- Generate portfolio and process metrics regarding BMS products.
- Utilize RIM knowledge to identify problems and lead problem solving efforts.
- Engage with stakeholders while resolving issues, ensure they understand data related procedures to achieve data accuracy.
- Maintain full proficiency of data standards, dictionaries, and naming conventions used with regulatory data.
- Verify and ensure correctness of submission data in the RIM system related to investigational trials and commercial product details. Utilize knowledge of the integration with R&D systems, the direction and frequency of data exchange as it pertains to RIM attributes.
- Demonstrate an understanding of dossier requirements for major and compliance submissions and be able to articulate this to peers.
- Monitor data quality by running RIM reports on applications, submissions and registrations. Provide information or metrics when requested. Utilize data views and evaluate query or report results to check process compliance and completeness of the data. Remediate issues. As needed, guide others on the use of reports and queries.
- Possess knowledge of regulatory practices, business rules and departmental procedures.
- Participate in improvement initiatives and special projects lead by others.
- Participate in RIM system testing and upgrades with expertise in validation practices that support a GxP environment. Run test scripts and document outcomes. Highlight script issues or technical errors. Train others on testing methods, as needed.
- Bachelors degree in scientific or technical subject with 2-4 years of industry experience.
- Solid understanding of drug development processes and regulatory knowledge.
- Experience with the procedures and decision-making process of government Health Authorities and it relates to RIM.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.