Maryland Green Jobs

Maryland Mobile Logo

Job Information

MMS Holdings Inc. Senior Regulatory Operations Specialist in Baltimore, Maryland

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit or follow MMS on LinkedIn ( .

Roles & Responsibilities:

  • Practices excellent internal and external customer service

  • In the project lead role:

  • Prepares and compiles documents for submission to regulatory health authorities

  • Publishes regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission ready standards by creating bookmarks, hypertext links, etc. using eCTD publishing tools and document management systems

  • Performs quality control checks to regulatory submissions to ensure compliance with ICH and company defined standards

  • Maintains regulatory submission tracking log and imports archival submissions into company document management system

  • Creates, formats, and reviews documents and references to meet style guide and submission ready requirements

  • Maintains submission project plans and tracks components

  • Conducts self-review of deliverables prior to release to clients

  • Maintains working knowledge of applicable regulations and ICH guidance documents; reviews proposed changes to identify process impact and supports implementation

  • Leads improvement efforts to departmental processes and recommends efficiencies

  • Demonstrates strong internal and external leadership skills

  • Complies with Document and Record Control Procedures

  • Complies with applicable Quality Management System and Information Security Management Systems policies and procedures; contributes input to updates

  • Assists IT with electronic document management and publishing systems testing to verify and validate operation and performance

  • Provides support and training to end users as needed on company style guide, template usage, and general processes that support regulatory submissions

  • Leads effort to create training materials and exercises; mentors new regulatory operation colleagues

  • Travels to client sites as necessary

Job Requirements:

  • Graduate degree preferred, or relent experience

  • 5+ years of experience in the Pharmaceutical, Biotech or CRO industries

  • Prior publishing experience required

  • Proficiency with MS Office and SharePoint applications

  • Self-motivated with developed skills in multi-tasking, attention to detail and follow-through

  • Excellent organizational, project coordination, and communication skills

  • Ability to multi-task efficiently