Senior Director, Regulatory Affairs

Purpose: Senior Director, Regulatory Affairs located in Ellicott City Maryland.

The selected candidate will be responsible for preparing and critiquing regulatory submissions such as INDs (clinical trials applications), full CTDs/NDAs, supplements, FDA meeting and planning strategy, as well as provide extensive strategic planning for regulatory issues related to drug development at all stages. In this role, you will review and sign-off of all regulatory submissions, for those projects designated as RA agent by client; review such submissions prepared by direct reports who are junior level personnel; and serve as liaison with FDA and/or other Agencies as requested by client. Additionally, IDS Sr. Management in defining and developing efficient internal systems for sharing and archival of strategic documents such as guidance and training programs; provide staff development as needed which includes hiring and supervision of direct reports and mentoring of junior staff members; work with internal Business Development to attract new clients for RA business. The medical writing and publishing group reports to this position.

The qualified candidate will have a Master's Degree (or equivalent) in Biomedical Science, and at least 10 years of experience. Must also possess good interpersonal skills and technical judgment, attention to detail, and ability to work independently. Experience with strategic preparation for FDA meetings required. Must also have extensive experience in regulatory writing.

Qualified candidates please apply today.

Keywords: Regulatory Affairs, CRO, IND, NDA, FDA

Classification:
Direct Placement

Compensation:
Negotiable Hour

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
IND/NDA, FDA COMPLIANCEContact Information
Contact:Majoros,Matthew E.