Global Regulatory Manager With Pharmaceutical

GLOBAL REGULATORY MANAGER WITH PHARMACEUTICAL LAWRENCEVILLE, NJ Position is 50% onsite. Location Lawrenceville, NJ. Manager is open to candidates working from the Summit, NJ site as well. Pay range 88.67 to 91.94. Project Description:

• 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 company 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 company 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.

Required Skills:

• Bachelor's 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.

This 6+month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #23-00962 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE