Regulatory Affairs Operations Specialist IV - Irvine, CA

ISTA Pharmaceuticals is a publicly traded (NASDAQ: ISTA) specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products for serious conditions of the eye.

 

ISTA is currently promoting three FDA approved products; IstalolTM (for the treatment of glaucoma), Vitrase® (for use as a "spreading agent") and Xibrom (a topical ophthalmic NSAID for the treatment of post cataract surgery inflammation and pain. Recently ISTA filed it's fourth product, T-Pred, a combination steroid antibiotic with the FDA. We have other prescription products under development, including ecabet sodium, for the treatment of dry eye,  Caprogel® for the treatment of hyphema, Iganidipine and Latanaprost for the treatment of glaucoma, and Bepreve TM for the treatment of ocular allergies.

 

In order to further build our pipeline as a specialty pharmaceutical company, we expect to acquire complementary products in ophthalmology, either already marketed or in late-stage development. Our management team has extensive experience in the development and commercialization of ophthalmic pharmaceuticals. Our Ophthalmology expertise can be found in the Marketing, Sales, Manufacturing, Clinical, Regulatory and General Management functions.

 

For an exciting future with an exciting company, visit our website: www.istavision.com and click on "Careers".

 

Job Title:  Regulatory Affairs Operations Specialist IV 
 
Location: Irvine, California 

 

Overall Purpose:

 

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.

 

Physical Demands and Work Environment

 

The physical demand described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

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

•  detail-oriented

•  experience with regulatory documentation (either authoring, review, QC or audit)

•  a well-developed understanding of quality standards for regulatory documents

•  excellent verbal, written and interpersonal skills

•  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.

 

 

ISTA Pharmaceuticals, Inc. offers 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