Senior Regulatory Affairs Operations Specialist

Job Description
Company Profile:
Welcome to Olympus Biotech. Olympus Biotech is dedicated to the further advancement of orthopedics and regenerative medicine to improve the lives of patients around the world. The Olympus Biotech Vision is to improve patient Quality of Life by developing and distributing regenerative medicines that stimulate the intrinsic healing capacity in the living body by the technological development of growth factors and biomaterials.

Job Summary:

This position supports the activities of the Regulatory Affairs Department with emphasis on submission preparation and publication; electronic documentation maintenance; developing and implementing department wide systems for control of information and document flow; maintaining knowledge of global regulatory requirements in support of preclinical, clinical and CMC activities for both marketed products and investigational products.

Qualifications/Work Experience Required:

∑ Experience supporting drugs or biologics both during development and post-commercialization is required.

∑ Experience in managing documentation compilation processes is required.

∑ Knowledge of and experience in electronic publishing.

∑ Excellent communications skills, presentation skills, and computer expertise.

∑ Ability to identify and solve complex problems which require analysis of situation or data.

∑ Works under limited direction on most activities. Determines and develops approach to solutions.

Education/Special Training Required:

Bachelorís Degree (or equivalent) preferred with five (5) to eight (8) years of regulatory operations experience.

Essential Duties & Responsibilities (detailed description):

∑ Support regulatory submission process design and implementation.

∑ Provide technical assistance for Olympus Biotech worldwide applications.

∑ Maintain a working knowledge of applicable guidelines, standards, and regulations and applying them as appropriate to Olympus Biotech activities.

∑ Compile submissions in paper and electronic format under limited direction.

∑ Recommend improvements in department systems and procedures for improved productivity and compliance.

∑ Manages the Official Regulatory File.

∑ Assist in the development of departmental procedures to improve consistency of work.

∑ Other activities as needed.

Company

Olympus Biotech Corporation

Job Code

State or Province

Pennsylvania

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