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Nda Project Manager Jobs (NOW HIRING)

Integrated Resources INC

Project Manager

Cambridge, MA · On-site

Projects may include product launches and product territory expansions, BLA/NDA filing activities, regulatory query responses and management or coordination for GVP and/or GCP inspection readiness.

Adare Pharma

Project Manager

Philadelphia, PA · On-site

The position will require Project Management of multiple ANDA/NDA development projects. This will involve working with the R&D management and team members to develop appropriate project management ...

adareps

Project Manager

Stevens Point, WI · On-site

The position will require Project Management of multiple ANDA/NDA development projects. This will involve working with the R&D management and team members to develop appropriate project management ...

Bright Mind Solutions LLC

Senior iOS developer

Austin, TX · On-site

$55 - $60/hr

... NDA project. This role involves working on both mobile development and server-side Swift, with a ... Strong understanding of scripting, deployment, and server management on Apache/Linux machines.

Intuitive

Project Manager, CMC

Sunnyvale, CA

Experience supporting NDA Module 3 preparation and submission * Experience managing CDMOs (and other suppliers) * PMP or comparable project management certification. * Familiarity with procurement ...

New

CEDENT

Senior Clinical Project Manager

Chicago, IL · On-site

Contribute to regulatory filings (e.g., IND / IMPD / CTN, NDA) * Identify issues and propose ... project management, and regulatory filings * Demonstrated ability to plan and execute Pharma ...

Intuitive

Project Manager, CMC

Sunnyvale, CA · On-site

Experience supporting NDA Module 3 preparation and submission * Experience managing CDMOs (and other suppliers) * PMP or comparable project management certification. * Familiarity with procurement ...

New

Intuitive Surgical

Project Manager, CMC

Sunnyvale, CA · On-site

Experience supporting NDA Module 3 preparation and submission * Experience managing CDMOs (and other suppliers) * PMP or comparable project management certification. * Familiarity with procurement ...

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How much do nda project manager jobs pay per year?

As of Sep 9, 2026, the average yearly pay for nda project manager in the United States is $112,681.00, according to ZipRecruiter salary data. Most workers in this role earn between $95,000.00 and $124,500.00 per year, depending on experience, location, and employer.

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NDA Regulatory Strategy Consultant (Remote)

Boston, MA • Remote

The FDA Group
Recruiting and Staffing Services • 11 - 50 employees
Learn more about The FDA Groupexternal

Full-time

Posted 18 days ago

Job description

NDA Regulatory Strategy Consultant

Location: Fully Remote
Work Arrangement: Remote
Start: Late Q4 2026 / Early Q1 2027
Schedule: Approximately 20 hours per week

Position Overview

We are seeking an experienced NDA Regulatory Strategy Consultant to provide senior-level strategic support during the final stages of New Drug Application (NDA) preparation for a life sciences organization.

The consultant will serve as a key regulatory advisor, providing overall strategic oversight of the NDA dossier and helping ensure the submission is complete, consistent, and positioned for FDA readiness. This individual will work closely with the existing regulatory project manager, regulatory writers, and internal stakeholders to review submission content, identify gaps and compliance risks, and maintain consistent regulatory messaging across the dossier.

This is a strategic but hands-on role requiring substantial direct NDA submission experience and the ability to operate independently with minimal guidance. The consultant may also serve as an interim senior regulatory lead while the organization recruits a permanent employee.

Key Responsibilities

  • Provide senior-level strategic oversight of the NDA dossier during final preparation.
  • Guide overall regulatory strategy and help ensure consistent messaging across the submission.
  • Review NDA content for completeness, consistency, compliance risks, and FDA readiness.
  • Identify regulatory gaps and recommend appropriate actions to address issues prior to submission.
  • Work closely with the regulatory project manager, writers, and internal team to maintain alignment across submission activities.
  • Provide practical regulatory guidance and decision support throughout the final stages of NDA preparation.
  • Apply hands-on NDA submission experience to anticipate potential FDA concerns and strengthen submission readiness.
  • Operate independently as a senior regulatory advisor with minimal oversight.
  • Potentially serve as an interim senior regulatory lead until a permanent regulatory employee is hired.

Required Qualifications

  • Significant hands-on experience preparing and supporting NDA submissions.
  • Strong knowledge of FDA regulatory expectations applicable to NDA preparation and submission.
  • Demonstrated ability to provide strategic oversight of complex regulatory dossiers.
  • Experience reviewing submission content, identifying regulatory gaps and compliance risks, and supporting FDA readiness.
  • Ability to collaborate effectively with regulatory project management, writing, and cross-functional internal teams.
  • Ability to operate independently and provide senior-level regulatory guidance with minimal direction.

Ideal Candidate

The ideal consultant is a seasoned regulatory professional with substantial hands-on NDA submission experience who can quickly step into a senior advisory role. This individual will combine strategic regulatory judgment with detailed dossier review capabilities and be comfortable serving as a trusted regulatory lead during a critical stage of submission preparation.