Regulatory Affairs Manager
Regulatory Affairs Manager
Posted on :
05-03-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
05-03-2025
Job Description
Responsibilities:
- With increasing independence you will support other Development team members with project and/or process administrative tasks of low complexity.
- Your responsibilities include but are not limited to supporting project communications conducting followup with project team members partners or stakeholders tracking project information helping maintain project timelines and performing other administrative work to support RPM colleagues and project team members.
- With close supervision and guidance you may also manage subprojects.
- Manages basic department/crossfunctional specific programs and/or initiatives.
- Manages basic project/initiative communications and works in partnership with seniorlevel 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 subteam 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 crossreference INDs original INDs and simpler RTQs.
- In relation to regulatory submissions tracks and prepares project information and activities including minutes timelines action items and functionspecific deliverables.
- Ensures integration of project timing scope and resources
- Works in partnership with seniorlevel 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 subteam updates and assists with preparation of formal presentations as required
- May implement routine process improvement and optimization initiatives as required.
- May manage subprojects 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:
- BA/ BS with 5 years relevant project management or scientific experience in the biopharma industry or 3 years relevant experience with an advanced degree.
- Relevant experience consists of work in a scientific field or equivalent experience with R&D project teams and/or crossfunctional project management activities
- 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 teamoriented 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.
Employment Type
Full Time
Key Skills
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