Global Regulatory Submissions Project Manager II

MMS; Austin (TX); Teletrabalho; USD 120 000 - 160 000; Tempo integral

Resumo da oferta

MMS Holdings Inc in Austin, TX is seeking a Regulatory Submissions Project Manager to lead IND, NDA, and MAA submissions with functional partners. You will coordinate cross-functional clinical, biometrics, regulatory writing, and regulatory operations teams to meet tight deadlines.

The role requires a bachelor’s degree and at least five years in project coordination or management, plus strong organization, communication, and budget stewardship.

Qualificações

• Bachelor’s degree or equivalent; at least 5 years in project coordination or PM.
• Expert knowledge of pharmaceutical development phases and NDA/MAA filing.
• Experience developing and managing integrated regulatory submission plans.
• Strong organizational, communication, collaboration and problem-solving skills.
• Experience managing project budgets, invoicing, profitability and utilization.

Responsabilidades

• Lead the planning and preparation of IND, NDA, and MAA submissions with functional leads.
• Partner with cross-functional teams to identify dependencies and adjust strategies to meet deadlines.
• Develop and maintain detailed submission timelines with critical paths and resources.
• Oversee multiple client engagements and prioritize a high-volume, complex workload.
• Lead project discussions, track progress, and provide status updates to stakeholders.
• Manage project budgets, revenue recognition, invoicing, profitability, and utilization.
• Contribute to RFP scoping and communicate the value proposition in business discussions.
• Partner with clients to understand needs and propose practical solutions.
• Identify opportunities to improve client satisfaction and relationships.
• Facilitate effective meetings with remote and global teams.
• Support continuous improvement of project processes and collaboration.
• Promote open communication across remote and global teams.

Conhecimentos

Regulatory submissions

Cross-functional collaboration

Budget management

Project coordination

Regulatory affairs

Communication skills

Formação académica

Bachelor’s degree or equivalent

Descrição da oferta de emprego

MMS Holdings Inc in Austin, TX is seeking a Regulatory Submissions Project Manager to lead IND, NDA, and MAA submissions with functional partners. You will coordinate cross-functional clinical, biometrics, regulatory writing, and regulatory operations teams to meet tight deadlines.

The role requires a bachelor’s degree and at least five years in project coordination or management, plus strong organization, communication, and budget stewardship.