Sr. Associate, Regulatory Operations - San Diego, CA | Biospace
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Sr. Associate, Regulatory Operations

Intercept Pharmaceuticals

Location:
San Diego, CA
Posted Date:
11/17/2016
Position Type:
Full time
Job Code:
Salary:
based on experience
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Pharmaceutical, Regulatory,

Job Description

POSITION SUMMARY:
The Senior Associate, Regulatory Operations will provide regulatory support for logistics, preparation, quality check, delivery and archiving of regulatory submissions in accordance with agency requirements and company standards.  Provide support, training, and management of the Electronic Document Management System (EDMS) and other software as assigned.

ESSENTIAL FUNCTIONS:
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
•   Support daily operational activities in preparation of global regulatory submissions
•   Format submission documents per Regulatory Style Guide and Company standards
•   Works with Regulatory Operations/Regulatory Affairs to ensure timely submissions
•   Ensure consistency, completeness, and adherence to agency guidelines, work instructions and SOPs
•   Manage multiple tasks in a fast paced environment while keeping on task and to the company’s quality standards
•   Maintain proficiency and expertise with the tools and processes associated with electronic regulatory submissions
•   Maintain Regulatory Affairs on-site archive storage
•   Provides support in the validation process for upgrades to validated electronic regulatory systems
•   Contribute to SOPs and work instructions to ensure regulatory documents, submissions, and systems are well-controlled and comply with applicable regulations
•   Assumes other relevant assignments as directed by the Head of Regulator

Requirements

QUALIFICATIONS:

•   Bachelor’s degree or relevant experience in the pharmaceutical industry
•   4-6 years Regulatory Operations experience, including EDMS administration




REQUIRED KNOWLEDGE AND ABILITIES:

•   Experience with electronic regulatory submissions, associated publishing tools, regulatory document control and management of EDMS
•   Knowledge of the submission and maintenance of global Clinical Trial Applications
•   Effective/productive working with minimal supervision
•   Knowledge of the regulations and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
•   Strong technical aptitude, preferably with extensive exposure to Microsoft Word, Adobe Acrobat
•   Good communication skills, both verbal and written
•   Exceptional attention to detail as well as organizational skills, including the ability to prioritize and multitask