Regulatory Submissions Project Lead

MMS Holdings Inc; United States; Remote; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

MMS Holdings Inc. is seeking an experienced regulatory submissions professional to join our data-focused CRO team. You will lead IND, NDA, and MAA submissions in partnership with clinical, biometrics, regulatory writing, regulatory affairs, and operations.

The role emphasizes coordinating timelines, managing budgets, and guiding global, remote teams to meet strict submission deadlines while delivering practical business solutions for clients in pharma, biotech, and medical device sectors.

Qualifikationen

• Bachelor's degree or equivalent relevant experience required.
• Expert knowledge of pharmaceutical development phases and NDA structure.
• Experience developing integrated regulatory submission plans with timelines and risks.
• Strong organizational and problem-solving skills.
• Experience managing budgets, invoicing and profitability.
• Ability to lead cross-functional, remote and global teams.
• Prior NDA/MMA filing experience preferred.

Aufgaben

• 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 submission timelines with critical paths and resources.
• Oversee multiple client engagements and a high-volume workload to meet deadlines.
• 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 clearly.
• Collaborate with clients to understand needs and propose practical solutions.
• Identify opportunities to improve customer satisfaction and client relationships.
• Facilitate effective meetings with remote and global teams.
• Promote continuous improvement of project processes and collaboration.
• Support open communication across remote and global teams.

Kenntnisse

Excellent communication

Cross-functional collaboration

Regulatory submission coordination

Budget management

Ausbildung

Bachelor's degree or equivalent

Jobbeschreibung

MMS Holdings Inc. is seeking an experienced regulatory submissions professional to join our data-focused CRO team. You will lead IND, NDA, and MAA submissions in partnership with clinical, biometrics, regulatory writing, regulatory affairs, and operations.

The role emphasizes coordinating timelines, managing budgets, and guiding global, remote teams to meet strict submission deadlines while delivering practical business solutions for clients in pharma, biotech, and medical device sectors.