Director, Regulatory Affairs Project Manager

Company: Crelate, Inc.
Location: Cambridge
Posted on: April 6, 2021

Job Description:

Director, Regulatory Affairs Project Manager Precision Life Sciences - Cambridge, MA POSITION DESCRIPTION This role will be responsible for project management activities including planning, coordination, and execution of high-quality regulatory submissions of original applications (i.e., NDAs, MAAs, INDs, IMPDs, CTAs) and any subsequent major amendments, supplements, and variations for assigned programs. The key focus of this position will be to oversee the regulatory filing of the company's first NDA/MAA. The person in the role will have the opportunity to establish and implement processes for planning Global Health Authority submissions. In addition, this person will maintain contact logs and databases and managing vendors to achieve corporate objectives, in compliance with company procedures, FDA regulations, and those of other global regulatory agencies. The candidate must have successfully demonstrated technical proficiency, creativity, initiative, independent thinking, and collaboration with others. This role provides the rare opportunity for a growing professional to develop their skills through collaboration with the senior-most levels of the organization while providing strategic and tactical impact. RESPONSIBILITIES -- Responsible for partnering across Regulatory (Strategic Regulatory, Medical Writing, CMC Regulatory, Ad-Promo Regulatory, and RegOps) and with cross-functional project teams to ensure regulatory timelines and strategies are developed and seamlessly executed upon, enabling successful filings with Global Health Authorities. -- Facilitates and co-leads product/submission-specific multi-disciplinary, cross-functional teams, working with all major contributors, including, but not limited to: Regulatory, Medical Writing, Preclinical, Biostatistics, CMC, QA, etc. to set expectations and ensure timelines are met. -- Develop and actively manages and monitors project timelines and integrated submission project plans to ensure timelines remain on schedule. -- Work with each function in detail to understand the individual deliverables and interdependencies between deliverables, in order to create and maintain an overall project plan timeline across all Modules (Modules 1-5). -- Identify and communicate both regulatory and project risks, with potential solutions to the cross-functional project team and leadership as needed. -- Prepare meeting agendas, meeting minutes, and document decisions, action items, and effective issue and risk mitigation plans. Organize and maintain this team information in a central location. -- Prepare and distribute reports and trackers to communicate updates and project status. -- Proactively drive project/submission teams and establish an appropriate level of urgency with a keen focus on deliverables. -- Manage the review cycles and any follow-up round tables as needed per the filing timelines. -- Plan, manage, attend and prepare for Regulatory Health Authority interactions and assist in documenting meeting minutes. -- Develop and implement plans for aligning key strategic messaging across submission components. -- Create policies and Standard Operating Procedures for processes related to global submissions -- Conduct lessons learned sessions to identify areas for improvement. -- Provide senior oversight, influence, and guidance to other submission project managers. -- Prepare monthly project reports, communicate, and present project status to the global project team and senior management. -- Standardize process to view/manage overall, cross-portfolio Regulatory submission workload and view dashboard of submission status. -- Tracks overview of all major submission and health authority activity to aid in Regulatory resource planning. -- Maintains up-to-date knowledge of health authority regulations and guidance documents as well as ICH guidelines. QUALIFICATIONS -- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred -- 10+ years pharmaceutical industry and substantial experience working within Regulatory Affairs with a fluent understanding of drug development -- Prior project management experience with NDA/BLA submissions and review is required -- Demonstrated experience in leading decision-making within cross-functional teams -- Excellent organizational and communication skills, both written and verbal -- Qualified project management experience; advanced expertise with project management related software and tools (i.e. MS Project, Sharepoint, etc) -- Ability to work independently as well as part of a team environment -- Positive attitude, energetic and proactive -- Strong interpersonal skills and the ability to effectively work with others

Keywords: Crelate, Inc., Cambridge , Director, Regulatory Affairs Project Manager, Executive , Cambridge, Massachusetts