Regulatory Affairs Manager III

Integrated Resources Inc.; Lower Gwynedd Township (Montgomery County); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading company in the workforce solutions sector is seeking a Manager for L&A Non-Portfolio Activities. This role includes project management for licensing and acquisitions, requiring strong leadership, quality systems experience, and a bachelor's degree. The ideal candidate will possess expertise in GxP environments and a collaborative mindset to drive project success.

Qualifications

• At least 9 years of experience in a related field within a medium to large matrix organization.
• Knowledge of drug development and GxP compliance.

Responsibilities

• Provide project management expertise for all L&A activities.
• Support the 90/100 DP Process by creating and managing project plans.
• Track and manage issues related to Due Diligence activities.

Skills

Leadership

Communication

Data Interpretation

Stakeholder Engagement

Conflict Resolution

Project Management

Education

Bachelor's degree

Job description

Integrated Resources, Inc., is led by a seasoned team with decades of industry experience. We deliver strategic workforce solutions that help manage talent and business efficiently. Since 1996, IRI has attracted and retained experts, enabling expansion into new sectors and steady growth.

Job Description

The Manager, L&A Non-Portfolio Activities, supports project management for the BRQC Licensing & Acquisitions Group. Responsibilities include maintaining L&A Portfolio and Non-Portfolio Trackers, producing the monthly L&A Dashboard, preparing meeting agendas, updating L&A Procedures, Playbooks, Guidance Documents, and supporting deviation/CAPA Management Processes for L&A Assessment Activities. Additional support includes managing 90/100 Day Assessment Plans and other projects as needed. The role requires a quality mindset and experience with Quality Systems/Management, ideally in GxP environments, including GCP, pharmacovigilance, and GLP activities.

Principal Responsibilities

1. Provide project management expertise for all L&A activities, including metrics/dashboard updates and document library maintenance.
2. Support the 90/100 DP Process by creating and managing project plans.
3. Track and manage issues related to Due Diligence activities.
4. Map, evaluate, and recommend improvements for Due Diligence, 90/100 DP, Divestment, and other processes.
5. Consolidate checklists used across the L&A Team for various activities.
6. Develop templates and agendas for BRQC L&A meetings.
7. Support additional BRQC Licensing and Acquisitions projects and attend team meetings.

This list is not exhaustive; other duties may be assigned.

Decision-Making and Problem-Solving

The role involves strategic support for quality projects, stakeholder collaboration, technical expertise, and reporting to management.

Reporting Relationships

The Manager reports to the Head of L&A within BRQC, functioning as a contractor using client equipment and training resources.

Qualifications

Education: Bachelor’s degree and at least 9 years of experience in a related field within a medium to large matrix organization, with knowledge of drug development and GxP compliance.

Related Experience: Strong leadership, communication, data interpretation, stakeholder engagement, conflict resolution, and project management skills. Experience in R&D, quality activities, and regulatory audits is advantageous.

Additional Information

Thanks!
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
Direct: 732-662-7964 | W: 732-549-2030 x219

Inc. 5000 – 2007-2015 (9 Years in a row)