Regulatory Submissions Project Manager

MMS; Chicago (IL); Teletrabalho; USD 110 000 - 160 000; Tempo integral

Resumo da oferta

MMS Holdings Inc is seeking a Regulatory Submissions Lead to drive IND/NDA/MAA submissions in collaboration with cross-functional teams. You will plan timelines, identify dependencies, and ensure on-time delivery for complex regulatory documents.

The role spans global teams, budget oversight, and client-facing discussions to articulate regulatory strategies and risks. A Bachelor’s degree plus 5+ years in project management or regulatory affairs is required.

Qualificações

• Bachelor’s degree or equivalent relevant experience.
• Expert knowledge of pharmaceutical development phases and NDA/MAA filing is preferred.
• Experience developing integrated regulatory submission plans with timelines and risks.
• Strong organizational and communication skills for stakeholder management.
• Experience managing project budgets, invoicing, and utilization.
• Ability to lead client-facing discussions with remote and global teams.

Responsabilidades

• Lead planning and preparation of IND, NDA, and MAA submissions with functional leads.
• Partner with cross-functional teams to identify dependencies and mitigate risks.
• Develop and maintain detailed submission timelines and resource needs.
• Oversee multiple client engagements and prioritize high-volume deliverables.
• Lead project discussions, track progress, and provide status updates to stakeholders.
• Manage project budgets, revenue recognition, invoicing, and profitability.
• Contribute to RFP scoping and communicate the company’s value proposition.
• Partner with clients to understand needs and propose practical solutions.
• Identify opportunities to improve customer satisfaction and relationships.
• Facilitate effective meetings with remote and global teams; promote collaboration.
• Support continuous improvement of project processes and outcomes.

Conhecimentos

Regulatory submissions

Project coordination

Budget management

Stakeholder communication

Cross-functional leadership

Global teams

Formação académica

Bachelor’s degree or equivalent relevant experience

Descrição da oferta de emprego

MMS Holdings Inc is seeking a Regulatory Submissions Lead to drive IND/NDA/MAA submissions in collaboration with cross-functional teams. You will plan timelines, identify dependencies, and ensure on-time delivery for complex regulatory documents.

The role spans global teams, budget oversight, and client-facing discussions to articulate regulatory strategies and risks. A Bachelor’s degree plus 5+ years in project management or regulatory affairs is required.