Regulatory Affairs Manager

Integrated Resources Inc.; Lower Gwynedd Township (Montgomery County); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in workforce solutions is seeking a Regulatory Program Manager to support regulatory activities in drug development. This role encompasses project management, resource planning, and collaboration with cross-functional teams to ensure compliance and efficiency. The ideal candidate will have a background in pharmaceuticals with strong project management skills.

Qualifications

• 3-5 years in (bio) pharmaceutical R&D experience, preferably in regulatory matrix organizations.
• Experience in project management and global dossier preparation preferred.
• Understanding of relevant regulations and guidelines.

Responsibilities

• Manage regulatory process from late development entry through launch.
• Develop regulatory scenarios and support risk identification.
• Own and maintain the GRA schedule in P5.

Skills

Project planning

Resource management

Regulatory processes

Education

B.S. or higher in a pharmaceutical-related field

Project management certification

Tools

Scheduling and resource management tools

Project planning tools

Job description

Integrated Resources, Inc., is led by a seasoned team with decades of industry experience. We provide strategic workforce solutions to help manage talent and business operations efficiently. Since 1996, IRI has attracted and retained experts, enabling us to expand into new sectors and grow steadily.

Job Description

Position Overview:

The RPM provides business support to GRA, assisting GRTs in resource planning using scheduling and resource management tools to support late development teams without dedicated RPMs in R&D. The role involves creating project and portfolio reports to support decision-making.

Program Management Support

Global Regulatory Team Support:

• Manage the regulatory end-to-end process from late development entry through launch.
• Represent Regulatory Program Management at GRT meetings, translating regulatory strategies into actionable deliverables.
• Develop regulatory scenarios to aid decision-making aligned with Regulatory and CDT strategies.
• Support early risk identification and mitigation planning.
• Collaborate with the Regulatory Leader to prepare for regulatory activities in GRT.
• Coordinate with Regulatory Liaisons on Health Authority interactions and submissions across NA, EMEA, and APJLA regions.
• Manage pre-submission activities in collaboration with Submission Operations as the primary contact.
• Lead cross-functional teams in executing pre-submission plans, managing Modules 1 and 2.
• Plan and oversee global regulatory activities, monitor milestones, and manage project budgets.

Schedule Management:

Own and maintain the GRA schedule in P5.

Project Management Team Support:

Represent Regulatory Program Management at the PMT, working closely with the CDT Program Management Leader and other managers to align strategies and manage regulatory development plans.

Qualifications

Education:

B.S. or higher in a pharmaceutical-related field; project management certification is a plus.

Experience:

• At least 3-5 years in (bio) pharmaceutical R&D, with preferred experience in regulatory matrix organizations.
• Experience in project management within drug development and global dossier preparation is preferred.
• Understanding of regulatory processes pre- and post-marketing, with knowledge of relevant regulations and guidelines.
• Proficiency in project planning, tracking, resource management, and analysis tools.