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Global Regulatory Manager

Trenton, NJ 08648

Posted: 06/02/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 566576-1 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 50-88.66/hr **salary will be commensurate with experience

Responsibilities:
  • 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.

Education:
  • Bachelors degree in scientific or technical subject with 2-4 years of industry experience.

Skills:
  • 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.

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 Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Trenton, NJ

Ready to take your career to the next level? Explore our job opportunities in the vibrant Trenton, New Jersey area! Nestled in the heart of the Garden State, Trenton offers a perfect blend of history, culture, and growth opportunities. From the stunning views along the Delaware River to the iconic Trenton War Memorial and historic State House, this city is rich in charm and history. Indulge in the local flavors of tomato pies and pork roll sandwiches, then immerse yourself in the thriving arts scene with visits to The Trenton City Museum at Ellarslie Mansion or catch a show at the Passage Theatre Company. With easy access to nearby Philadelphia and New York City, endless outdoor adventures in Mercer County Park, and the excitement of catching a game at CURE Insurance Arena supporting the Trenton Thunder, there's no shortage of reasons to consider Trenton for your next career move. Explore our job listings today and set your sights on a bright future in this dynamic region!

Although this hasn't been an issue at Planet Pharma, 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 Planet Pharma.