Global Regulatory Affairs Consultant

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Job description

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, 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 the company has been recognized as a leading CRO in Global Health & Pharma's international awards programs for the last three consecutive years. For more information, visit or follow MMS on LinkedIn.

Responsibilities

• Coordinates with Sponsors and Regulatory Operations Team on the management of large submissions.
• Acts as POC for Regulatory submissions.
• Advises on annual reports (US and global, usually DSUR).
• Gives advice on harmonization of US and Global submissions (e.g., coordinated IND and IMPD writing, management of IB and Protocol amendments across regions, etc.).
• Provide guidance globally for EU/ EEC countries, for regulatory development of novel drugs in specialty therapeutic areas to include Rare/ Orphan disease areas (from early development covering CTA enabling studies to late stage phase 3 development), or for established drugs seeking new indications/ dosage forms for small biotech companies
• Reviews, gives advice on, and/or writes regulatory documents including expedited. approval applications, orphan applications, meeting requests, and briefing docs.
• 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, INDs, NDAs MAAs - oversees planning and execution of major submissions and responses to regulatory authorities related to CTAs, INDs, amendments, aggregate reports, NDAs, MAAs 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.
• 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 guidelines.
• 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 improve overall efficiency, quality, and/or output.

Requirements

• 5 + years' experience in pharmaceutical or CRO industry preferred.
• Self-motivated with excellent skills in multi-tasking, attention to detail and follow-through.
• Excellent organizational, project coordination and communication skills.
• Proficiency with MS Office and SharePoint applications.
• Graduate degree preferred in related discipline / industry but not required.

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