26 Jul
Associate Director / Director Regulatory Operations
Vacancy expired!
- A creative and independent thinker that supports all communications with cross functional teams
- Work closely with Regulatory Affairs, Program Management, and Product Development Teams to provide operational oversight and support.
- Assist with the planning, preparation, tracking, and timely submission of all eCTD applications and updates to global health authorities (e.g. IND, NDA, BLA, MAA, etc.).
- Tracking regulatory commitments and deliverables to health authorities.
- Managing all activities and communications with third-party technical writers and publishing organizations.
- Maintaining an index and archive of all regulatory submissions and correspondence.
- Providing input and guidance on current technical aspects of submission requirements such as CDISC nonclinical and clinical data set requirements, etc.
- Maintaining and improving Sharepoint site used for authoring of regulatory documents.
- Monitor and asses business trends, pending regulations or guidance documents and emerging technologies for potential regulatory operations impact, develop action plans, business tools, and countries requirements guides accordingly.
- Budgeting and forecasting activities, including managing expenditures activities related to approved vendor contracts
- BS Required and advanced degree preferred (MS/PhD/PharmD)
- Ability to work with diverse stakeholders and build strong, collaborative relationships to include managing competing agendas and priorities across different functional departments
- Excellent oral and written communication
- 7+ years regulatory affairs in bio/pharma industry
- Experience managing a team of direct reports
Vacancy expired!