Project Manager, PMTA Programs

Description
About McKinney Regulatory Science Advisors

McKinney Regulatory Science Advisors (MRSA) helps clients thrive in a regulated environment by providing regulatory, scientific and stakeholder engagement leadership. We are passionate about guiding companies of all sizes successfully through every step of a complex regulatory process.
At McKinney Regulatory Science Advisors, we're not just shaping the future of nicotine product testing; we're creating a workplace where talented professionals can grow and thrive. We offer competitive compensation and a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k)-retirement plan.
Position Summary

The Project Manager, PMTA Programs is responsible for managing client Premarket Tobacco Product Application (PMTA) programs from initial planning through FDA submission and post-submission activities. This role oversees project timelines, budgets, scope, and deliverables while coordinating cross-functional teams in chemistry, toxicology, clinical and behavioral science, and regulatory affairs.
The Project Manager serves as the primary point of contact for clients and works closely with internal subject matter experts, external laboratories, manufacturers, and suppliers to ensure projects are completed on time, within budget, and in accordance with quality expectations. While scientific and regulatory experts are responsible for technical decisions, the Project Manager ensures effective coordination, communication, issue resolution, and overall project execution.
Projects may range from individual product applications to large, multi-product portfolios across various tobacco and nicotine product categories.
Essential Responsibilities

Program Planning and Delivery

Build and maintain the integrated master schedule for the entire program, covering administrative sections, writing summaries, product chemistry, HPHC and stability testing, nonclinical toxicology, clinical and behavioral studies, perception studies, environmental assessment and manufacturing sections.
Explicitly link laboratory reports, supplier documents, scientific analyses, narratives, reviews, and submission assembly in the schedule.
Define scope, work breakdown structures and resource plans; track progress against milestones and the critical path.
Track deliverable owners, due dates, acceptance criteria, and objective evidence of completion; maintain a submission-readiness tracker showing ready, in progress, blocked, and deferred items.
Run gap assessments against current FDA CTP requirements, guidance and the PMTA content rule (21 CFR Part 1114), and translate gaps into workplans.
Lead Work Stream Owners to coordinate technical gap assessments with qualified regulatory SMEs rather than independently determining scientific or regulatory sufficiency.
Coordinate assembly, QC and electronic submission of applications, amendments and responses to deficiency letters.
Develop recovery plans for threatened milestones and coordinate documented submission-versus-amendment decisions with authorized regulatory and client stakeholders.
Client and Stakeholder Management

Serve as primary client contact; lead kickoffs, status meetings and steering committees.
Lead decision-oriented meetings that produce documented decisions, named owners, deliverables, and firm follow-up dates.
Support preparation for FDA pre-submission meetings and correspondence.
Manage expectations, escalated risks early and document decisions and change requests.
Translate technical issues into concise executive updates identifying impacts, options, recommendations and decisions required.
Team Coordination

Direct internal subject-matter experts and writers across concurrent workstreams.
Lead through influence across Work Stream Owners, internal SMEs, laboratories, suppliers, manufacturers, and client teams; establish roles, handoffs, and escalation paths.
Surface resource conflicts early, challenge unsupported commitments constructively, and facilitate working sessions focused on removing blockers.
Financial Management

Own budgets, forecasts, invoicing milestones and margin.
Monitor estimates to complete, scope changes, and financial variances; escalated pricing or contract decisions through approved commercial authority.
Prepare estimates and contribute to proposals and statements of work for new and expanding engagements.
Quality and Risk

Maintain risk and issue registers, RAID logs and lessons learned.
Maintain explicit dependency and decision logs, with mitigation owners, dates, and critical-path impacts.
Ensure deliverables follow firm SOPs, document control and data-integrity (ALCOA+) practices.
Lead in distinguishing, organizing and managing draft, received, reviewed, approved, and submission-ready documents; verify completion against acceptance criteria.
Travel Requirements

Approximately 10-20% travel, based on client and business needs.
Qualifications

Bachelor's degree in any discipline.
5+ years of project or program management, with at least 3 years in a regulated product environment (tobacco, pharmaceutical, medical device, food or consumer product).
Proven ownership of budgets, schedules and client relationships on concurrent engagements.
Proficiency with MS Project, Smartsheet or equivalent scheduling tools, and Microsoft 365.
Clear written and verbal communication with technical and executive audiences.
Eligibility to handle Controlled Unclassified Information (CUI) and work in U.S. jurisdiction as required by client contracts.
Demonstrated leadership of multidisciplinary teams without direct reporting authority, including difficult stakeholder conversations and conflict resolution.
Experience managing integrated dependencies, evidence-based deliverable completion, and recovery of at-risk projects.
Ability to provide concise, decision-ready executive reporting and elevate risks with options and consequences.
Preferred Qualifications

PMP, PgMP or RAC certification.
Experience with FDA eSubmitter, the CTP Portal and eCTD-style document assembly.
Familiarity with analytical testing methods (ISO/CORESTA), HPHC reporting and stability study design.
Background in a consulting or client-service firm.
Experience with current FDA CTP electronic submission workflows, including CTP Portal NextGen, version control, and submission QC.
Experience coordinating external laboratories and suppliers on fixed-date regulatory submissions.
The above statements are intended to describe the general nature of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties and skills required of employees so classified.
We believe in transparent compensation practices. The expected salary range for this position is $105,000.00 - $120,000.00 per year. Starting pay will be based on the candidate's qualifications, experience, and the required job.
Application Process

McKinney Regulatory Science Advisors is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. McKinney Regulatory Science Advisors does not discriminate in hiring or employment practices based on race, color, religion, gender, age, sexual orientation, marital or familial status, national origin, non-job-related disability or status as a veteran.
McKinney Regulatory Science Advisors is an equal opportunity employer. We celebrate diversity and are committed to creating inclusive environment for all employees. McKinney Regulatory Science Advisors does not discriminate in hiring or employment practices based on race, color, religion, gender, age, sexual orientation, marital or familial status, national origin, non job-related disability, or status as a veteran.

J-18808-Ljbffr