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Regulatory Affairs Operations Specialist IV Job
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| Employer Name: PRA Corp. |
SpiderID: 2233578 |
| Location: Irvine, California |
Date Posted: 5/22/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5843 |
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Job Description:
Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications this will include working with all departments (R&D, Operations, Regulatory Affairs, Clinical Research/Operations, Medical Affairs and Quality Assurance to implement processes and quality control checks to ensure all information provided in the context of regulatory submissions is accurate, complete and meets regulatory document specifications.
Duties & Responsibilities:
• Leadership role in the validation process for any upgrades to the currently validated regulatory publishing system. This includes working with IT and the vendor to manage the validation of systems in a timely manner.
• Responsible for the creation and compilation of quality global Regulatory submissions and lifecycle management submissions. This includes facilitating the development of electronic systems and planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic formats.
• Ensure process for submission of regulatory document is performed in accordance with established procedures.
• Plan and prepare regulatory submissions to FDA and other regulatory agencies using paper and/or electronic publishing tools. This includes, executing the daily activities involved with the preparation, QA and assembly processes involved with submissions.
• Manage official regulatory files in paper and electronic form. This includes receiving and organizing component documents from paper and/or electronic sources.
• Support various task force activities related to new applications and supplements.
• Creates and maintain tracking systems for component pieces of submissions.
• Ensure conformance with regulatory requirements, guidelines, internal standards and timelines.
• Establish and implement processes for departmental SOPs as well as the generation of electronic submission-ready documents. This includes developing training materials, providing training and technical/document support to internal disciplines and external contractors.
• Liaise with external vendors in support of regulatory submissions.
• Maintain the Regulatory Archive Database layout updates, changes and upgrades.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the FDA and ICH.
We offer a competitive package of cash compensation, benefits, work-life programs, and conveniences. Employment is contingent on a successful drug-screening result, and we maintain a smoke-free work environment. We are an equal opportunity employer committed to diversity in the workplace. EOE/AA/M/F/D/V.
Job Requirements:
Education & Experience
• Bachelor's Degree or demonstrated industry experience.
• 5-10 years pharmaceutical industry experience.
• Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic.
• Proficiency with MS-Office Suite and Adobe Acrobat applications.
Knowledge & Abilities
• Strong technical knowledge of electronic publishing systems and software.
• Superior Organizational skills.
• Must be Detail-oriented.
• Must have experience with regulatory documentation (either authoring, review, QC or audit).
• Must have a well-developed understanding of quality standards for regulatory documents.
• Must have excellent verbal, written and interpersonal skills.
• Must have experience in working effectively in cross-functional teams.
• Ability to work under strict deadlines and changing priorities with minimal supervision on routine assignments.
• Self-starter with superior time management skills, and ability to work independently or in teams.
• Ability to effectively manage resources to achieve business objectives.
For immediate consideration, please forward a copy of your current resume to libbie@profrecruiters.com referencing job #5843.
Job Criteria:
Start Date: asap
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: Libbie |
Company Type: |
| Company: PRA Corp. |
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| City: Carlsbad |
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| State: California |
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| Zip: |
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Web Site: http://www.profrecruiters.com
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