Global Regulatory Affairs Manager

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 www.mmsholdings.com or follow MMS on LinkedIn.

• Reviews, gives advice on, and/or writes regulatory documents including expedited approval applications, orphan applications, meeting requests, and briefing docs.
• Coordinates with Sponsors and Regulatory Operations Team on the management of large submissions
• Acts as POC for US regulatory submissions
• Advises on annual reports (US and global, usually DSUR)
• Gives advice on harmonization of US and Global submissions (e.g., VHP, coordinated IND and IMPD writing, management of IB and Protocol amendments across regions, etc.)
• Coordinates with clinical CROs and local Authorized Agents on global regulatory submissions (overarching PM, ensuring TMF compliance, managing versioning, coordinating responses to queries and information requests)
• Responsible for working with internal and external teams, as well as vendors, to manage short- and long-term global regulatory activities that support the success of investigational and marketed pharmaceutical products throughout their lifecycle, including the compilation, preparation, coordination, review, and submission to Health Authorities
• Works with cross-functional teams to coordinate regulatory agency (RA) and other central or country level authority submissions to ensure timelines are met.
• Demonstrates an excellent understanding of country requirements for CTAs, NDAs, and INDs - oversees planning and execution of major submissions and responses to regulatory authorities related to INDs, CTAs, amendments, aggregate reports, NDAs and supplements within company timelines and in accordance with regulations and guidelines.
• Represents Regulatory Operations as the primary contact on global regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective/considerations at a project level in team meetings.
• Tracking, reporting of central submission/approval progress, and archiving of all regulatory activity in applicable MMS systems.
• Provides oversight into the creation/maintenance of project plans and input for timelines
• Oversees the completeness of project deliverables by conducting expert reviews prior to release to client
• Provides strategic input and technical guidance on regulatory requirements to project teams including oversight for the publishing of regulatory submissions according to ICH electronic
• Works closely with the publishing team by providing deliverables to publishing once submission ready documents are received
• Monitors impact of changing regulations on submission strategies and updates internal and external stakeholders; participates in implementation as applicable
• Maintains in-depth knowledge of applicable regulations and ICH guidance's
• Demonstrates excellent leadership skills and customer service both internally and externally
• Works closely with the Global Regulatory Operations department to lead departmental initiatives to improve overall efficiency, quality, and/or output.

• Graduate degree preferred in related discipline / industry
• 5 + years’ experience in pharmaceutical or CRO industry preferred
• Prior supervisory experience preferred
• Proficiency with MS Office and SharePoint applications
• Self-motivated with excellent skills in multi-tasking, attention to detail and follow-through
• Excellent organizational, project coordination and communication skills
• Familiarity with ISO 9001:2008 requirements

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