US-MD: Gaithersburg-Manager/Senior Manager, Regulatory Affairs
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Job Title: Manager/Senior Manager, Regulatory Affairs
Job Location: MD: Gaithersburg
Pay Rate: Open
Job Length: full time
Start Date: 2008-07-24
Company Name: MedImmune
Contact: Human Resources
Phone: email only please
Fax: email only please
Description: Manager/Senior Manager, Regulatory Affairs Department Name: Regulatory Affairs Location: Gaithersburg Job ID Number: 4511-010 Job Description
Position Summary: The Regulatory Compliance Manager will function as the liaison between Regulatory and other functional groups to ensure compliance with applicable US and worldwide regulations and guidelines pertaining to GxP (GLP, GCP, GMP).
Major Duties and Responsibilities: Act as Regulatory Affairs liaison in conjunction with other functional areas to identify, analyze and resolve regulatory compliance issues. Manage follow up of regulatory commitments and coordinate periodic reporting of status to regulatory agencies. Identify and communicate regulatory best practices for compliance within Medimmune. Write and update Regulatory SOPs, policies and work practices pertaining to GxP. Review and approve Regulatory and other functional area SOPs and work practices pertaining to GxP and regulatory commitments where required. Meet routinely with functional areas on behalf of Regulatory Affairs for non-project-specific GxP issues. Train Regulatory Affairs personnel on GxP compliance issues; also train functional new or changing GxP regulatory requirements. Advise Regulatory Affairs and other departments on and propose policy for various GxP compliance issues [including CROs used in clinical trials, financial disclosure, labeling, promotions and advertising, audits/inspections, and inspection readiness]. Review validation protocols, templates and reports, confer with the appropriate Regulatory Affairs Project Manager and provide consistent and consolidated RA feedback. Assist in review of labeling, advertising and promotional materials as required. Assist with internal compliance audits of functional areas and external sites/vendors as requested. Maintain up-to-date knowledge of GxP regulations and guidelines. Act as Lead RA Inspection Readiness Coordinator and maintain associated documentation. Participate on MedImmune Project Team Meetings as required. Assist Clinical and QA in Regulatory Agency inspection preparedness.
Job Requirements
Education:BS/MS in a scientific discipline or equivalent experience. Experience:Minimum of five years experience with GxP compliance; a total of 5-7 years of industry experience. Knowledge of FDA and worldwide GxP regulations, guidelines and standard industry practices. Job Complexity:Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinate(s), colleagues and other departments to meet schedules and/or resolve technical problems. Supervision:Manages and coordinates the activities of all GxP issues for the Department, with responsibility for results in terms of costs, methods and employees.
* MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
Please refer to Job code medimmune-3472 when responding to this ad.
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