Senior Manager, Regulatory Project Management - Contract - Cambridge, MA
Proclinical is seeking a Sr. Manager, Regulatory Project Manager for a leading pharmaceutical company. This is a contract position located in Cambridge, MA.
Primary Responsibilities:
The role is focused on R&D project management for late-stage global regulatory filings. The successful candidate will be responsible for developing and optimizing detailed regulatory project plans and timelines, maintaining real-time filing timelines, and facilitating critical filing team meetings. This role is crucial in ensuring that timelines and deliverables for NDA/MAA filings are mutually understood and agreed upon.
Skills & Requirements:
- Bachelor's degree in a scientific or medical field preferred with at least 6 years' experience in the biotechnology or pharmaceutical industry.
- Demonstrated project management skills with the ability to prioritize multiple projects.
- Experience developing project plans, content plans, and other filing tools.
- Proficiency in technical systems such as Smartsheet, MS Project, Visio, Excel, Veeva, SharePoint.
- Excellent organizational and meeting management/facilitation skills.
- Excellent written and verbal communication skills, including negotiation skills.
- Ability to work in a fast-paced environment and driven to succeed.
- Ability to problem solve, identify bottlenecks, and escalate issues appropriately in a timely fashion.
- Working 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.
The Senior Regulatory Project Manager will:
- Develop and optimize detailed regulatory project plans and timelines in collaboration with various leads.
- Maintain real-time filing timelines and track deliverables through NDA/MAA 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.
- Develop document reviewer matrix and coordinate reviews and roundtables as needed.
- 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 of NDA/MAAs.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) 617-830-1769 or b.forsen@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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