Job Board

Quality Regulatory Specialist, NeuroSystec (5/1/08)

NeuroSystec Corporation is a medical technology company that is developing unique implantable, drug-delivery devices and compounds for the treatment of neurological diseases and hearing disorders. These products will overcome limitations of systemic side effects by combining localized drug delivery with highly potent therapeutic agents. By applying the advances in delivery systems to recently developed neuron active compounds, we are developing combination products in order to bring relief to people suffering from previously untreatable conditions. Our focus is tinnitus, neuron protection following trauma to the hearing system and other diseases of the middle and inner ear. Due to its expanding program, NeuroSystec is currently seeking a Quality-Regulatory Specialist.

Job Description:

The Quality-Regulatory Specialist is responsible for assisting in the regulatory and quality aspects of drug and device development projects including the preparation of and maintenance of various quality and regulatory documents including IMPD/CTA, IND/NDA and CMC. The position will be responsible for ensuring that the quality, accuracy and format of regulatory submissions comply with applicable laws, regulations and corporate standards. The position will also require the ability to organize and compile IMPD and IND submissions to regulatory agencies to ensure regulatory compliance, conduct Quality & Regulatory training, active participation in the CAPA program, ensure conformance to 21 CFR and ICH regulations, and assist in development of relevant regulatory and quality SOPs. As time is available, assist in the project management of key company programs.

Qualifications and Competencies:

The position requires a bachelor degree in science and/or a related field. Five to ten years of quality-regulatory experience in biopharmaceutical environment and/or training; equivalent combination of education and experience will be evaluated. The candidate must be able to working a team-based environment. Excellent interpersonal, oral and presentation skills are crucial for this position as well as strong English written language skills and computer skills, including the suite of Microsoft Office.

NeuroSystec offers competitive salary and benefits packages, including medical, dental, vision, life insurance, 401k with Company match, and stock options. NeuroSystec is an equal opportunity employer. For more information about our company please visit our website: www.NeuroSystec.com or email us your resume and other information to the address below or to HR@NeuroSystec.com.  Please refer to Job Code # QRS-211 in your email or introduction letter when mailing your resume to us.

Mann Biomedical Park, 25134 Rye Canyon Loop, Suite 370, Valencia, CA 91355

Phone: (661)702-6880 Fax: (661)702-6715 website www.neurosystec.com

Back to Job Board