Regulatory Project Manager and Filing Excellent Consultant

Proclinical is seeking a dedicated and experienced Regulatory Project Manager and Filing Excellence Consultant for a biopharmaceutical company. This role will focus on developing and implementing best practices for preparing major global regulatory filings. The successful candidate will work closely with various teams and management to facilitate timely submission of high-quality data packages to US and international health authorities.

Responsibilities:

• Project management for late-stage global regulatory filings.
• Develop and optimize detailed regulatory project plans and timelines in collaboration with various teams.
• Maintain real-time filing timelines and track deliverables through submission and registration.
• Facilitate and co-lead critical filing team and sub-team meetings.
• Maintain project dashboard for sharing progress and risks with senior management.
• Identify and highlight project interdependencies.
• Coordinate reviews and roundtables as needed per the filing timelines.
• Plan and facilitate cross-functional workshops focused on execution of submission strategy.
• Coordinate lessons learned sessions and ensure implementation of feedback for process improvement.
• Contribute to the development of best practices and standardized process for filing.

Key Skills and Requirements:

• Bachelor's degree in a scientific or medical field.
• Demonstrated project management skills with the ability to prioritize multiple projects.
• Experience developing project plans, content plans, and other filing tools.
• Proficiency in Smartsheet, MS Project, Visio, Excel, Veeva, SharePoint.
• Excellent organizational and meeting management/facilitation skills.
• Strong interpersonal skills to work effectively with other departments at various levels.
• Excellent written and verbal communication skills, including negotiation skills.
• Ability to work in a fast-paced environment and driven to succeed.
• Problem-solving skills, with the ability to identify bottlenecks and escalate issues appropriately.
• Understanding of regulations and experience in interpretation of Health Authority guidelines.
• Experience with regulatory filings, original NDA/BLA/MAA and response to questions is a plus.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.