Senior Project Manager, Regulatory Submissions

MMS; Austin (TX); In loco; USD 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

MMS is seeking a seasoned Regulatory Submissions Project Manager in Austin, TX to lead IND, NDA, and MAA submissions with cross-functional teams across global sites. The role emphasizes timelines, risk mitigation, and stakeholder communication to ensure timely regulatory filings.

The ideal candidate brings 5+ years in project management within pharmaceutical development, strong organizational skills, and a collaborative mindset to drive complex projects forward.

Competenze

• Bachelor’s degree or equivalent relevant experience.
• 5+ years in project coordination or project management.
• Expert knowledge of pharmaceutical development phases and NDA/MAA structures.
• Experience developing integrated regulatory submission plans with timelines and resources.
• Strong organizational and communication skills; ability to work with remote, global teams.

Mansioni

• Lead planning and preparation of IND, NDA, and MAA submissions with regulatory authorities.
• Partner with cross-functional teams to identify dependencies and mitigate risks.
• Develop and maintain detailed submission timelines with critical paths.
• Oversee multiple client engagements and high-volume deliverables.
• Track progress, provide metrics, and report status to stakeholders.
• Manage project budgets, invoicing, profitability, and utilization.
• Contribute to RFP scoping and communicate value proposition.
• Support client needs and recommend practical business solutions.
• Foster effective collaboration across remote and global teams.
• Identify opportunities to improve processes and outcomes.
• Promote open communication across teams.

Conoscenze

Project coordination

Project management

Regulatory submissions

Cross-functional collaboration

Budget management

Stakeholder communication

Formazione

Bachelor's degree or equivalent

Regulatory affairs knowledge

Descrizione del lavoro

MMS is seeking a seasoned Regulatory Submissions Project Manager in Austin, TX to lead IND, NDA, and MAA submissions with cross-functional teams across global sites. The role emphasizes timelines, risk mitigation, and stakeholder communication to ensure timely regulatory filings.

The ideal candidate brings 5+ years in project management within pharmaceutical development, strong organizational skills, and a collaborative mindset to drive complex projects forward.