Global Regulatory Submissions Project Lead

MMS; Raleigh (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

MMS Holdings, a data-focused clinical research organization, seeks a seasoned project manager to lead regulatory submissions for INDs, NDAs, and MAAs. You will collaborate with clinical, biometrics, regulatory writing, and regulatory affairs teams to align timelines and deliverables, ensuring deadlines are met for complex programs.

The role demands strong organization, communication, and financial oversight, including budgeting and profitability.

Qualifications

• Bachelor's degree or equivalent in life sciences or related field.
• 5+ years in project coordination, project management, or related experience.
• Experience with regulatory submissions processes (IND, NDA, MAA).
• Strong organizational, communication, and problem-solving skills.

Responsibilities

• Lead planning and preparation of IND, NDA, and MAA submissions with regulatory authorities.
• Collaborate with clinical, biometrics, regulatory writing, and regulatory operations teams to meet deadlines.
• Develop and maintain submission timelines with dependencies and critical paths.
• Manage multiple client engagements with a high-volume, complex workload.
• Provide project metrics, status updates, and risk assessments to stakeholders.
• Oversee budgets, invoicing, profitability, margins, and utilization.
• Contribute to RFP scoping and communicate the company value in business discussions.
• Engage with clients to understand needs and propose practical solutions.
• Identify opportunities to improve client satisfaction and long-term relationships.
• Facilitate meetings with remote/global teams and resolve conflicts.

Skills

Regulatory submission planning

Project coordination

Cross-functional leadership

Budget management

Stakeholder management

Regulatory affairs knowledge

Pharmaceutical development knowledge

Education

Bachelor's degree or equivalent in life sciences or related field

Job description

MMS Holdings, a data-focused clinical research organization, seeks a seasoned project manager to lead regulatory submissions for INDs, NDAs, and MAAs. You will collaborate with clinical, biometrics, regulatory writing, and regulatory affairs teams to align timelines and deliverables, ensuring deadlines are met for complex programs.

The role demands strong organization, communication, and financial oversight, including budgeting and profitability.