CMC Regulatory Affairs Project Manager I
2 weeks ago
Position Overview:
This role is 100% remote and focuses on the management of Chemistry, Manufacturing, and Control (CMC) regulatory activities.
Key Responsibilities:
- Oversee project management for variations of marketed products, including the preparation and compilation of CMC documentation to ensure timely submissions.
- Utilize electronic document management systems effectively.
- Exhibit exceptional oral and written communication abilities.
- Demonstrate the capacity to work autonomously under pressure while managing multiple projects concurrently.
Qualifications:
- A minimum of a BA/BS Degree in Chemical, Biological Sciences, or a related field.
- At least 4 years of experience in the pharmaceutical industry or a related field.
- 1-2 years of experience in quality systems or cross-functional project management.
Business Context:
This position is essential for managing CMC and Device Post Approval Changes and responding to agencies regarding the product portfolio.
The role involves directing activities and personnel associated with projects of varying scales, focusing on non-IT business applications and disciplines.
Manage all aspects of single or multiple, complex, mission-critical projects throughout the Full Project Life Cycle.
Collaborate with project sponsors, business units, and users to define project scope, develop initiatives, implement requirements, assign and guide project staff, and ensure successful project outcomes.
Deliver high-quality project solutions to address business challenges within established budgets and timelines. Provide expert guidance and support throughout the project lifecycle, including tracking, reporting, and presenting to management and stakeholders.
Experience Level: 1-3 Years.
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