CMC Regulatory Affairs Project Manager -… at ObjectWin… · Foster…

Company Description

ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects and fulltime resource deployments. We serve our customers both nationally and globally.

Job Description

• Job Title: CMC Regulatory Affairs Project Manager
• Duration: 6 Months
• Job Location: 333 Lakeside Drive, Foster City, CA 94404

No Remote, No C2C – USC/GC holders only

Description: The CMC Regulatory Affairs Project Manager will be responsible for tracking the status of key filings for clinical and commercial programs for all global markets. The Project Manager will communicate with the cross functional CMC teams on small molecule and biologics submissions tracking. The Project Manager will attend CMC regulatory meetings and will be responsible for maintaining timelines, meeting minutes, action items, resource plans and other project documents.

Job Responsibilities:

• Facilitate communication of regulatory activities across CMC Sub-Teams and Senior Management
• Work on an improved tool for the regulatory department to track submissions
• Generate metrics on regulatory submissions and approvals across a wide-array of submission subtypes.
• Tracking of regulatory filings for clinical and commercial programs for all global markets
• Develop and manage detailed project timelines for regulatory activities
• Monitors project execution and adjusts plans
• Facilitates communication and documentation of regulatory activities across project teams and senior management
• Collaborates with the team to resolve issues and organizes team to execute on the corrective actions
• Ensures project work complies with established practices, policies and processes

Qualifications

• Minimum 6 years of relevant experience and a BA or BS or 4 + years of relevant experience and a MS or MBA. Relevant experience consists of work in cross functional biopharmaceutical /pharmaceutical CMC development, GMP and regulatory affairs
• Excellent organizational skills, capable of setting priorities and delivering on commitments, while managing high workload
• Strong communication skills; written and verbal including oral presentation skills
• Experience in regulatory CMC project management is preferred
• In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio, SharePoint and other reporting/tracking tools

Additional Information

If this position be of interest to you, please contact me directly at 832-485-3662