Regulatory Affairs Project Manager

Summary of Position

The Regulatory Affairs Project Manager will facilitate the success of key regulatory projects by coordinating regulatory activities, deliverables, and submission content across Regulatory Affairs Staff and cross-functional teams.

In this capacity, the individual will work to improve the organization and tracking of internal department projects and deliverables that drive success against the project timeline and FDA approval.

Under general supervision, this position will also facilitate the success of key company projects by supporting department Directors and Managers in tracking project action items, milestones, and deliverables across functional areas.

Effective communication with the international department and across multiple languages is essential to this position. Additional responsibilities will include facilitating regulatory data flow.

Essential Functions

• Manage project submissions as assigned by Regulatory Affairs leadership, including department work process.
• Manage key projects, planning, timing, and execution for submission, approval, and launch.
• Maintain project database for tracking individual and department project deliverables.
• Manage incoming requests through logging, assigning, tracking, working with RA staff to manage complexity and difficulty, and maintaining department metrics.
• Maintain database and tracking of key department deliverables
• Facilitate regulatory electronic submission software to allow a more efficient compilation process.
• Foster a collaborative environment by working closely with RA staff assigned to projects, a key strategy to mitigate RA resource conflicts and manage multiple, sometimes conflicting priorities.
• Maintain and track deliverables
• Share expertise with peers.
• Other duties as assigned or requested by Regulatory Affairs leadership.

Requirements

• Bachelor Degree in technical discipline, pharmaceutical industry, or related life science preferred.
• Project Management Experience - Certification Preferred
• 3 or more years Regulatory Affairs support of submission content, compilation, or publishing
• 3 or more years Project Management experience in Pharmaceutical or Heath related industry
• Ability to facilitate decision making specific content expertise may reside with team members
• Experience in Project set-up / initiation, executions, and completion within established timeframes
• Must be able to communicate clearly in English and have solid communication skills including grammar and composition.
• Building Effective work streams and work process
• Team Member and Team Leader experience on cross functional teams.
• Strong evidence and mastery of being a Team Contributor Experience with regulations associated with Investigational, New Chemical Entity, and Generic drug applications preferred.
• Experience with International Cross Functional Teams
• Attention to detail and overall drug application quality and internal consistency.
• Strong decision making skills
• Excellent written and oral communications skills.
• Strong interpersonal, and negotiation skills, conflict management, priority setting, strategic agility, building effective teams, managing vision and purpose.
• Proficiency in computer skills (Microsoft Office Project, Access. Excel, Document Management Systems)

Working Conditions :

• This position will work in typical office conditions with extensive time using personal computer equipment.
• May be required to sit or stand for long periods of time while performing duties.
• Close attention to detail required.
• Willingness to work in a team-based environment.
• The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required.
22 days ago