Assoc. Dir, Regulatory Affairs-CMC
$142,400–$224,100 year
On-siteNorth Wales, Pennsylvania, United States or Rahway, New Jersey, United States
Job Summary
Drive AI-enabled regulatory authoring capabilities, including Module 2/3 innovations and practical job aids, while assessing emerging technologies for Regulatory CMC processes. Lead cross-functional activities to develop digital and AI tools that maximize productivity, partnering with R&D and Manufacturing divisions to integrate solutions across enterprise workflows. Serve as the primary point of contact for key digital platforms like the ERA App, supporting priority tracking, progress reporting, and change management for AI adoption. Mentor digital project teams and interns, fostering collaboration within the broader AI/Digital Enablement community.
Required Qualifications
- Minimum BS or equivalent Scientific, Technical, or Regulatory degree (focus on chemistry, biology, pharmacy, computer science, or data analytics preferred)
- Minimum of five (5) years of experience in the pharmaceutical or biotech industry
- Strong background in Regulatory CMC, Regulatory Affairs, or related pharmaceutical technical operations
- Hands-on experience developing, implementing, or optimizing digital tools, automation, and modern AI/LLM solutions in a regulated business setting
- Demonstrated experience delivering enterprise-wide solutions that improve business outcomes
- Experience in technical change management, with a capability to design repeatability assessments, job aids, and training materials for end-users
- Experience mentoring and coaching colleagues or interns on digital projects and technical workflows
- Strong collaboration and communication skills, with a proven ability to work effectively in a matrix environment across various functional units (such as research, manufacturing, and IT)
- Strong organizational and project coordination skills, with the ability to manage multiple overlapping initiatives simultaneously
- Change Management
- Collaboration
- Electronic Common Technical Document (eCTD)
- Emerging Technologies
- Interpersonal Relationships
- Liaison Work
- Manufacturing Processes
- Multitasking
- Project Leadership
- Regulatory Affairs Management
- Regulatory CMC
- Regulatory Compliance
- Regulatory Documents
- Regulatory Experience
- Regulatory Management
- Regulatory Reporting
- Regulatory Strategy Development
- Regulatory Submissions
- Stakeholder Partnerships
- Up to 10% Travel
Desired Qualifications
- focus on chemistry, biology, pharmacy, computer science, or data analytics preferred
- Experience in technical change management, with a capability to design repeatability assessments, job aids, and training materials for end-users
- Experience mentoring and coaching colleagues or interns on digital projects and technical workflows
- Strong collaboration and communication skills, with a proven ability to work effectively in a matrix environment across various functional units (such as research, manufacturing, and IT)
- Strong organizational and project coordination skills, with the ability to manage multiple overlapping initiatives simultaneously
- Change Management
- Collaboration
- Electronic Common Technical Document (eCTD)
- Emerging Technologies
- Interpersonal Relationships
- Liaison Work
- Manufacturing Processes
- Multitasking
- Project Leadership
- Regulatory Affairs Management
- Regulatory CMC
- Regulatory Compliance
- Regulatory Documents
- Regulatory Experience
- Regulatory Management
- Regulatory Reporting
- Regulatory Strategy Development
- Regulatory Submissions
- Stakeholder Partnerships
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