REGULATORY AFFAIRS ASSOCIATE I

Management Recruiters of Wrightsville Beach, The Port City Group, Inc. currently represents a very strong growing pharmaceutical company with many opportunities in research and development including the following position near Research Triangle Park, North Carolina

Please do not apply to this position if you do not have experience working in regulatory affairs within the pharma or biotech industries.

Regulatory Affairs Associate

Ensure all CMC documentation and regulatory submissions are prepared to meet global regulatory standards and provide information for US and worldwide submissions.
? Produce approvable CMC components of regulatory dossiers with appropriate manufacturing flexibility.
? Provide regulatory input on project teams.
? Work with QA, QC and Manufacturing to assure that all regulatory requirements are met.
? Advise on the creation and revision of SOPs governing CMC activities.
? Review and approve all changes to manufacturing processes to ensure compliance with global regulatory guidelines.
? Advise project teams, Operations, Quality, and R&D on appropriate specifications for raw materials, manufacturing components, process intermediates, and finished products to assure adequate regulatory controls for the life cycle of all regulated products.
? Performs other related duties as assigned.

Requirements
? 0-4 years experience in Regulatory Affairs
? BS degree (advanced degree preferred) in a related technical or scientific discipline
? Ability to communicate effectively orally and in writing.
? Ability to function independently.
? Highly organized.
? Capable of supporting numerous projects simultaneously.
? Strong interpersonal and communications skills, collaboration/teamwork, and adaptive skills required.
? Knowledge of US and ICH requirements for investigational drug development and post-approval compliance.
? Ability to travel as needed
? The Company values its employees and strives to make the company a safe place to work ? safety is a basic responsibility of each employee. All employees are required to follow the intent and spirit of all safety and health policies, procedures or practices, whether written or verbally communicated to the employee.

MANAGEMENT RECRUITERS OF WRIGHTSVILLE BEACH IS AN EXECUTIVE SEARCH FIRM SPECIALIZING IN THE PHARMACEUTICAL AND BIOTECH INDUSTRIES.
ALL RESUMES ARE CONFIDENTIAL AND ONLY QUALIFIED CANDIDATES WILL BE CONTACTED.

Qualified candidates must send resume, cover letter highlighting strengths for the position and daytime contact information to Amanda Troy, Executive Recruiter with MRI of Wrightsville Beach ? The Port City Group, Inc. (billonehr@bellsouth.net)