Global Regulatory Submissions Lead (IND/NDA/MAA)

MMS; Philadelphia (Philadelphia County); Teletrabalho; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

MMS Holdings Inc. seeks a Senior Regulatory Submissions Project Manager in Philadelphia to lead complex IND, NDA, and MAA submissions.

You will coordinate with clinical, biometrics, regulatory writing, regulatory affairs, and regulatory operations to ensure on-time delivery and compliance. The ideal candidate brings 5+ years in project coordination/management, deep NDA/MAA knowledge, and strong budget and stakeholder management skills to drive successful regulatory submissions for pharmaceutical

Qualificações

• Bachelor’s degree or equivalent with relevant experience in regulatory submissions.
• 5+ years in project coordination/management or related field.
• Expert knowledge of pharmaceutical development phases and NDA/MAA structure (preferred).
• Experience developing and managing integrated regulatory submission plans with timelines, dependencies, and risks.
• Ability to manage multiple client engagements and deliverables in a high-volume environment.
• Strong organizational, communication, collaboration, and problem-solving skills.

Responsabilidades

• Lead planning and preparation of IND, NDA, and MAA submissions with regulatory authorities.
• Partner with cross-functional teams to identify dependencies and mitigate risks to meet deadlines.
• Develop and maintain detailed submission timelines and critical paths.
• Oversee multiple client engagements and a high-volume workload to meet submission deadlines.
• Lead project discussions, build consensus, and provide status updates to stakeholders.
• Manage project budgets, invoicing, profitability, margins, and utilization.
• Contribute to RFP scoping and communicate value in business discussions.
• Partner with clients to understand needs and propose practical solutions.
• Identify opportunities to improve client satisfaction and relationships.
• Facilitate meetings with remote and global teams and promote collaboration.
• Support continuous improvement of project processes and outcomes.

Conhecimentos

Regulatory submissions planning

Cross-functional leadership

Project management

Budget management

Stakeholder communication

Risk management

Formação académica

Bachelor's degree or equivalent

Descrição da oferta de emprego

MMS Holdings Inc. seeks a Senior Regulatory Submissions Project Manager in Philadelphia to lead complex IND, NDA, and MAA submissions.

You will coordinate with clinical, biometrics, regulatory writing, regulatory affairs, and regulatory operations to ensure on-time delivery and compliance. The ideal candidate brings 5+ years in project coordination/management, deep NDA/MAA knowledge, and strong budget and stakeholder management skills to drive successful regulatory submissions for pharmaceutical