Regulatory Affairs Manager III
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!
location: Cambridge, Massachusetts
job type: Contract
salary: $119.34 - 140.40 per hour
work hours: 9 to 5
Manage one or more cmpany assets from approximately 18 months from a major submission through potential approval. Submission Planning Lead works directly with the Global Regulatory Leader to develop a filing strategy, facilitate the development of submission timelines, and manage the execution of the plans by interacting with the cross-functional team. Anticipate hire will manage one or more company assets from approximately 18 months from a major submission to through potential approval and support Wave 1 global submissions.
1) Lead submission teams by setting direction, escalating issues, establishing project management tools.
2) Lead scenario discussions to determine best submission dates, Health Authority reviews, and ROW filing strategies.
3) Facilitate development and tracking of key messaging, issue identification and resolution, problem-solving, risk management, contingency planning, and decision making.
4) In conjunction with the Global Regulatory Lead, chair meetings essential to submission success, such as Kick-off meetings and Submission Team meetings.
5) Creates a detailed project plan for Initial filing and ROW wave submissions, manages critical path and Risk log.
1) Preferred 5 years of regulatory and proven project management experience navigating a team through a major full submission such as a NDA/BLA or MAA with at minimum a 4 year college degree.
2) Masters in Regulatory Affairs or RAC a plus
1) Proficient in developing and managing an overall cross functional project plan through the use of a project management software platform, such as MSP.
2) Experience developing visualizations, identifying risks and tracking and manging risk mitigations.
3) Demonstrated ability to resolve conflict and influence teams.
skills: Project Management, NDA
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.