Project Manager, Regulatory Affairs CMC
Posted Updated 7
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Description
Job Summary
The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient resource management, and clear communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high-quality deliverables, and implements process improvements. Resource management is crucial, along with fostering a collaborative team environment. Ultimately, this role ensures RACMC filings are submitted and approved on time, and to the required regulatory standards, contributing to the organization's success and regulatory compliance.
Responsibilities
- Coordinate global regulatory dossier generation and submission activities as a project manager.
- Coordinate biologics CMC change control activities and related regulatory submissions across development and commercial products.
- Coordinate regulatory activities across multiple submissions, variations and change control projects
- Support global project and submission teams with project management expertise.
- Create and maintain regulatory project and submission plans, schedules, and resources.
- Identify and manage regulatory submission risks and issues.
- Conduct regular project meetings and provide updates to stakeholders.
- Collaborate with internal stakeholders to successfully implement regulatory projects, submissions until approval.
- Monitor submission progress and report project team and submission status to Global RACMC management.
- Develop and implement process improvements to enhance project efficiency.
- Oversee, manage and maintain IT tools, processes and knowledge management sites.
- Drive adoption and effective use of AI and digital tools within RACMC processes
Qualifications
Education Qualifications
- Bachelor's Degree Bachelor or Master's degree in Life Science or Pharmacy required Master's Degree preferred
Experience Qualifications
- Minimum of 5 years of experience in the pharmaceutical industry required
- Minimum of 3 years of experience in regulatory affairs required
- Project Management knowledge and experience preferred
- Experience in Regulatory Affairs CMC; biologics experience preferred.
- Proven ability to plan, coordinate and lead projects simultaneously on multiple projects preferred
- Proficiency in AI-enabled workplace tools (e.g. Microsoft Copilot)
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization preferred
- Experience of working in global environment in interdisciplinary teams preferred
- Knowledge of project management tools and processes preferred
Travel Requirements
Ability to travel up to 10% of the time. International travel may be required