Regulatory Affairs Project Manager
4 days ago
The Regulatory Affairs Project Manager is a key member of the Global Regulatory Affairs team at BioSpace, Inc. This role is responsible for facilitating timely submission of high-quality data packages to US and international health authorities. The successful candidate will work closely with cross-functional teams to develop and maintain integrated project timelines, including BLA/MAA and other marketing application timelines.
Key Responsibilities:
- Develop and maintain overall integrated project timelines, specifically including BLA/MAA and other marketing application timelines
- Develop and maintain dashboards to identify and monitor critical items in preparation of global filings
- Provide project management support to the global Regulatory team for key agency interactions
- Support CMC Regulatory in development of timelines to support submission amendments
- Proactively identify potential issues, constraints, bottlenecks, risks, and mitigation management and escalates issues, as needed; propose solutions to support decision-making
- Communicate with leadership and program teams in a concise and timely manner
Requirements:
- Bachelor's degree in a scientific field preferred with at least 10 years' experience in biotechnology or pharmaceutical industry
- Demonstrated project management skills with demonstrated ability to prioritize multiple projects
- Experience developing project plans and content plans and other filing to
- Prior experience as lead project manager for BLA or NDA; understanding of must-haves vs. nice-to-haves for regulatory filings
- Strong technical system proficiencies particularly Smartsheet, MS Project, Visio and Excel, Veeva, SharePoint
- Excellent organizational and meeting management/facilitation skills
- Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels
- Excellent written and verbal communication skills, including negotiation skills, with the ability to communicate at all levels of the organization
- Persuasively convey ideas and suggestions for forward momentum
- Skilled at translating regulatory, operational, and business knowledge into effective implementation plans and strategies
- Comfortable with negotiation and challenging the status quo to bring forward innovative solutions
- Strong attention to detail with the propensity to document at the right level
- Ability to identify roadblocks and provide direction to teams to explore alternative solutions or paths
About BioSpace, Inc.
BioSpace, Inc. is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, BioSpace is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. BioSpace has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
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