Regulatory Project Manager

Job Title : Regulatory Project Management (RPM)

Location : FC preferred but open to remote candidates

Duration : Contract

EXAMPLE RESPONSIBILITIES :

Manages basic department / cross-functional specific programs and / or initiatives.

Manages basic project / initiative communications and works in partnership with senior-level Project Management to ensure that all stakeholders are fully informed and knowledgeable of project activities and their status.

Provides Regulatory Project Management support for assigned programs / projects / initiatives; may attend sub-team meetings.

Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate.

Identifies and manages critical path activities.

Supports 1 2 Regulatory Projects, including but not limited to cross-reference INDs, original INDs, and simpler RTQs.

In relation to regulatory submissions, tracks and prepares project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources.

Works in partnership with senior-level Project Management and / or Project Lead to ensure timely, efficient and effective meetings and progress on activities between meetings.

Works in partnership with senior Project Manager and / or Project Lead to execute on deliverables.

May coordinates basic team operations and communications.

Works with senior Project Management to generate periodic project team and sub-team updates and assists with preparation of formal presentations as required.

May implement routine process improvement and optimization initiatives as required.

May manage sub-projects as assigned.

Focuses on operational tasks, learns how to manage submissions independently, and starts to develop a strategic mindset.

Ensures project work complies with established practices, policies and processes and any regulatory or other requirements.

REQUIREMENTS :

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

BA / BS with 5 years relevant project management or scientific experience in the biopharma industry, or 3 years relevant experience with an advanced degree.

A scientific background is preferred.

Relevant experience consists of work in a scientific field or equivalent experience with R&D project teams and / or cross-functional project management activities.

PMP (Project Management Professional) or other PM certification or equivalent is a plus.

Knowledge & Other Requirements

Knowledge of the drug development process.

Modest knowledge of regulatory requirements specific to key regions such as the US and EU, and have a general awareness of current global and regional trends in Regulatory Affairs.

Experience in assisting with multiple projects and flexibly adapting to changing priorities.

Experience in assisting with project scope, timelines and deliverables.

Awareness of Agile Methodologies and their application in the R&D biopharma environment.

Organizational awareness and knowledge of change management with the ability to support senior Project Management in an evolving environment.

Ability to communicate in a clear and concise manner.

Ability to support team-oriented, highly-matrixed environment.

Ability to execute multiple tasks as assigned.

Must be quality driven individual with strong attention to detail and accuracy.

Ability to support an inclusive environment of empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration.

Knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools.