Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Regulatory Affairs Specialist

Expired Job

I-Hire Pleasanton , CA 94588

Posted 5 months ago

  1. After introduction to organization, policies, and procedures, works independently on assigned projects under general supervision and is responsible for regulatory project and/or program management, and records of regulatory activities. Follows timelines for identified projects, and project action items.
    2.Assists with the development of appropriate formats for electronic documents. Assists with electronic transfers of files, and creates status reports to circulate both within the department and other company stakeholder departments.
    3.Assists with regulatory projects, including international registration filings.
    4.Helps with database(s)maintenance.
    5.Interacts with Regulatory Affairs staff to assist in the coordination and preparation of registration filings.
    6.Uses discretion and independent judgment to implement or suggest solutions for process improvements.
    7.Utilize internal/cross-functional/customer relationships.

    Skills:
    Minimum: 2 years of design control experience in a medical device or IVD company in Development/Operations/Quality/Regulatory

Skills:
2 years of design control experience in a medical device or IVD company in Development/Operations/Quality/Regulatory
Contract


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director/Director Regulatory Affairs CMC

Gritstone Oncology, Inc.

Posted 3 days ago

VIEW JOBS 1/14/2019 12:00:00 AM 2019-04-14T00:00 Position Summary Gritstone Oncology is a fast-growing, innovative biotechnology company developing the next generation of personalized cancer immunotherapies. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors, and very deep financial backing to tackle fundamental challenges at the intersection of cancer biology, immunology and immunotherapy design. The goal is to develop breakthrough immunotherapy treatments for patients with cancer by identifying and deploying neoantigens from each patient's tumor to develop personalized cancer vaccines. Gritstone Oncology is headquartered in the San Francisco Bay Area with certain key functions located in Pleasanton, CA and Cambridge, MA. The primary role of this position is to lead the Regulatory Chemistry, Manufacturing & Controls (CMC) aspects of one or more products in development through interaction with multiple functions to facilitate the development of innovative oncology therapeutics from early phase clinical trials through to worldwide submission and approval. Specific responsibilities include: * Participation in or leadership of cross-functional subteams, development of regulatory strategies, and support for oncology development programs * Preparation, coordination, review, and maintenance of high quality regulatory submissions that support product development strategy and ensure complete CMC content that meets current regional requirements * Preparation of technical assessments of CMC source documentation and responses to technical questions on document content * Identification and implementation of process improvements which have an impact on Regulatory Affairs and/or other departments * Involvement in preparation for and direct participation in CMC-related interactions with regulatory health authorities Minimum Education/Experience * BS/MS degree (or equivalent) in life sciences, advanced degree preferred * 8+ years of experience in regulatory affairs CMC within a biotechnology company * Direct experience managing regulatory CMC aspects of investigational biologic products essential, including strong knowledge of analytical characterization and release tests; process scale-up, transfer, and validation; GMP manufacturing facility and equipment * Experience with virus vaccines, gene transfer, or cell therapy products Other Qualifications * Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with all levels of management and contract manufacturing organizations * Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment; able to react nimbly to changes in timelines and strategy * Strong knowledge of cGMP for biologic products and manufacturing facilities; understanding of the biopharmaceutical development lifecycle * Self-motivated, self-disciplined, and able to function independently as well as part of a team * Strategic agility, strong critical and logical thinking with ability to analyze and propose innovative solutions to problems * Excellent computer proficiency (MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document management systems) careers@gritstone.com Gritstone Oncology, Inc. Pleasanton CA

Regulatory Affairs Specialist

Expired Job

I-Hire