Regulatory and Quality Specialist I
The Regulatory Specialist I is responsible for supporting Regulatory Affairs and Quality Operations with submissions to Global Health Authorities, Quality Documentation and associated activities.
Duties and Responsibilities
• Format documents for consistency with Style Guide and relevant standardized terminology
• Quality control (QC) review of submission and quality documents
• Consolidate comments on draft regulatory submission documents
• Assist in preparing electronic submissions, including publishing submission documents consistent with La Jolla’s standards and industry best practices
• Assist the Regulatory department with regulatory information management utilizing Veeva RIM (i.e. Electronic archival, Regulatory Commitments, Submissions)
• Maintain archive of original paper regulatory documents
• Prepare and ship paper submissions to health authorities
• Maintain the company’s library of literature references Manage or assist with Regulatory activities for submissions
• Assists with Execution of submission plans; coordinating activities between relevant functions; tracking progress against plan and effectively managing deadlines (ie, Annual Reports)
• Assist QA to plan and coordinate required audits; track and coordinate receipt of audit documentation utilizing Veeva Quality Docs
• Coordinate vendor qualification process, including collection and review of questionnaires and other required documentation; assist with scheduling audits
• Assist with maintenance, reconciliation and tracking of training curriculum
• Support reconciliation and tracking of training records
• Assist with processing SOPs and maintenance of Glossary of Terms;
• Assist with other regulatory or quality activities and special projects, as needed
• Education and experience:
o Bachelors degree in a life science or relevant discipline preferred
o Recent exposure to regulatory affairs and/or operations experience in pharmaceutical and/or biotech product development
• Specialized knowledge:
o Strong competency in Microsoft Word, Power Point and Excel
o Strong competency in Adobe Acrobat
Other skills and abilities:
o Detail oriented, organized and committed to quality and consistency
o Deadline driven, capable of managing competing high-priority assignments
o Excellent written and verbal communication skills
o Excellent team-interaction skills and ability to work successfully in cross-functional teams
o Ability to work in a dynamic environment with a high degree of flexibility
This position will require approximately 80% of time spent in an office environment sitting at a computer. Activities comprising the remaining 20% (meetings, conferences, co-worker interactions) will require moving between offices and buildings and some travel.
NOTE: This Job description is not intended to be all-inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization.
To inquire about any of our employment opportunities, please forward your resume and a cover letter to Human Resources .
La Jolla Pharmaceutical Company is an equal-opportunity employer.