Regulatory Submissions Project Lead (IND/NDA/MAA)

MMS; Boston (MA); Teletrabalho; USD 120 000 - 160 000; Tempo integral

Resumo da oferta

MMS Holdings Inc, a data-focused clinical research organization, seeks an experienced regulatory submissions program manager to lead IND, NDA, and MAA filings. You will partner with cross-functional teams to meet submission deadlines and deliver high-quality regulatory documents.

The role requires developing timelines, managing budgets, and coordinating global teams to ensure compliant, timely submissions and strong client relationships.

Qualificações

• Knowledge of pharmaceutical development phases and NDA/MAA filing processes.
• Experience creating and managing integrated regulatory submission plans and timelines.
• Strong organizational and communication skills with stakeholder-focused solutions.
• Experience managing budgets, profitability, margins, and resource utilization.
• Proven ability to lead client-facing discussions and coordinate global teams.

Responsabilidades

• Lead IND, NDA, and MAA submissions with regulatory authorities.
• Coordinate with clinical, biometrics, regulatory writing, regulatory affairs, and regulatory operations teams.
• Develop and maintain submission timelines, dependencies, critical paths, and contingency plans.
• Oversee multiple client engagements and deliverables to meet deadlines.
• Provide project metrics, status updates, and risk communications to stakeholders.
• Manage project budgets, revenue recognition, and invoicing to ensure profitability.
• Assist with RFP scoping and communicate the company’s value proposition.

Conhecimentos

Regulatory submissions

Cross-functional leadership

Project management

Timeline planning

Budget & invoicing

Formação académica

Bachelor’s degree or equivalent

Descrição da oferta de emprego

MMS Holdings Inc, a data-focused clinical research organization, seeks an experienced regulatory submissions program manager to lead IND, NDA, and MAA filings. You will partner with cross-functional teams to meet submission deadlines and deliver high-quality regulatory documents.

The role requires developing timelines, managing budgets, and coordinating global teams to ensure compliant, timely submissions and strong client relationships.