Clinical Regulatory Affairs Manager

Purpose: Our clients in Rockville,MD are looking for a Regulatory Affarirs Manager, please see the description below-


The Regulatory Affairs Manager provides regulatory support to the Senior Director, Director, Associate Director, or Assistant Director for the global development of the one or more investigational projects and/or marketed projects.

Serves as the primary regulatory representative to Project Team for assigned projects or products.

Provides guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.

Interacts with Project Managers at FDA, when requested by supervisor.

In conjunction with supervisor, determines regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products.

Reviews documents intended for submission to FDA to assure compliance with regulatory standards.

For assigned projects, completes all regulatory submissions.

Conducts independent regulatory research


The qualified candidate will possess the following:

Three or more years of regulatory experience in the pharmaceutical industry or equivalent, or 5 or more years of Clinical Drug Development experience.

Advanced degree, PhD, Pharm D, or MD or bachelor's degree and 7-10 years experience.

Working knowledge of the drug development process (particularly INDs and NDAs), drug laws, regulations, and guidelines.

Good understanding of the FDA organization.

Good oral and written communication skills including the ability to discuss scientific/technical data and regulatory requirements with senior management and FDA personnel.

Good knowledge of ICH guidelines regarding preparation of clinical study reports and investigator brochures.



Please contact Patrick Stedman @ 410-567-8008 for more information about this position.Classification:Contract-to-HireCompensation:
negotiable YearJoin 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:
REGULATORY AFFAIRS, CLINICAL RESEARCHContact Information
Contact:Stedman,Patrick Henry