Senior Clinical Submissions Manager (IND/NDA)

MMS; Phoenix (AZ); Teletrabalho; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

MMS Holdings Inc in Phoenix, AZ is seeking a Regulatory Submissions Project Manager to lead IND, NDA, and MAA submissions and coordinate across clinical, regulatory, and operations teams. You will manage timelines, risks, and budgets to ensure timely, compliant submissions.

The role requires a Bachelor's degree or equivalent experience, strong communication skills, and experience with NDA/MAA filings. A collaborative, global team environment and strategic client interaction are key aspects of

Qualificações

• Bachelor’s degree or equivalent relevant experience.
• Expert knowledge of pharmaceutical development phases and NDA structure; NDA and MAA filing experience strongly preferred.
• Experience developing and managing integrated regulatory submission plans with timelines, dependencies and risks.
• Strong organizational, communication, collaboration, and problem-solving skills.
• Experience managing project budgets, invoicing, profitability, margins, and utilization.
• Ability to manage multiple client engagements and concurrent deliverables while handling a high-volume workload.
• Experience leading client-facing discussions and collaborating with remote, global teams.
• Working knowledge of CRO operations and the drug development process.

Responsabilidades

• Lead planning and preparation of IND, NDA, and MAA submissions with regulatory authorities.
• Partner with cross-functional teams to identify dependencies, mitigate risks, and meet deadlines.
• Develop and maintain detailed submission timelines with critical paths and resources.
• Oversee multiple client engagements and deliverables to meet submission deadlines.
• Lead project discussions, track progress, and provide status updates to stakeholders.
• Manage project budgets, revenue recognition, invoicing, profitability, margins and utilization.
• Contribute to RFP scoping and communicating value to clients in business discussions.
• Partner with clients to understand needs and propose practical business solutions.
• Identify opportunities to improve client satisfaction and relationships.
• Facilitate effective meetings with remote and global teams and promote collaboration.

Conhecimentos

Project management

Regulatory submissions

Budget management

Cross-functional coordination

IND/NDA submissions

Communication

Formação académica

Bachelor's degree or equivalent experience

Descrição da oferta de emprego

MMS Holdings Inc in Phoenix, AZ is seeking a Regulatory Submissions Project Manager to lead IND, NDA, and MAA submissions and coordinate across clinical, regulatory, and operations teams. You will manage timelines, risks, and budgets to ensure timely, compliant submissions.

The role requires a Bachelor's degree or equivalent experience, strong communication skills, and experience with NDA/MAA filings. A collaborative, global team environment and strategic client interaction are key aspects of