Regulatory Director

HIGH PRIORITY
Title: Regulatory Director/Associate Director (experience level depending)
Temp only - until the end of year
100% remote, must be based in the US. EST timezone is highly prefred preferred.
Interviews will be virtual
Pay: flexible to market, see what folks are asking for. Most important to find an excellet quality candidate ASAP. The want someone to start before 17th or 18th due to a resgination. However, will wait for the right candidate.
Job Description
Postion Summary: The Global Regulatory Lead is responsible for the global regulatory strategy and execution.
Key Accountabilities:
Represent Regulatory Affairs in Global Project Team(s) for your assigned project(s).
Lead the regulatory sub-team (GRST) for your assigned project(s). Ensure alignment of all GRST functions.
Drive the regulatory submission process for all types of submissions through to approval. This includes the management and coordination of the preparation of all regulatory documentation, and ensuring all submission deliverables are of high quality. Partner with Regulatory Project Management and Submission Management.
Ensure optimal management of major regulatory agency interactions for your assigned projects including preparation of briefing materials, co-ordination of rehearsals and minutes. This may be done by an experienced Regional Regulatory Lead with strong support from the GRL.
Develop optimal regulatory strategies that are aligned with the development plan for assigned projects.
Matrix leadership role of GRST ensure project resource requirements are suitably managed.
Participate in cross-functional and GRA initiatives
Required Skils:
Advanced degree and at least 6 years of relevant experience
A minimum of 3 years of recent oncology experience
Experienced strategist with a record of successful HA interactions with FDA or EMA
Demonstrated strong matrix leader
Excellent spoken and written English