Skip navigation
Unable to save this job. Please try again later.

{msg}

Email this Job to Yourself or a Friend

To begin the application process, please enter your email address.

Company Contact Info

  • Culver City, CA
  • Sara Finley

Already have an account?

Sign in to apply with your saved resumes.

New to CareerBuilder?

Don't have an account? Continue as a guest!

Sorry, we cannot save this job right now.

Report this Job

Trust and Site Security Team.

Email Send Failed!

Manager Regulatory Operations

Ascent Life Sciences • Culver City, CA

Posted 28 days ago

Job Snapshot

Full-Time
Experience - At least 4 year(s)
Degree - 4 Year Degree
Pharmaceutical, Biotechnology
Pharmaceutical, Biotech
23

Applicants

How Do You Compare to the Competition?

Get facts about other applicants with a CareerBuilder Account

Job Description

Manager, Regulatory Operations
Los Angeles, CA
Permanent/FTE
 
 
RESPONSIBILITIES:
  • Coordinate daily operational activities for preparation of US and global regulatory submissions
  • Contribute to US and global Regulatory Operations strategy and resource allocation to ensure quality and timely submissions
  • Represent Regulatory Operations in cross-functional submission-planning and timeline meetings
  • Provide functional and technical guidance to more junior Regulatory Operations team members
  • Regulatory formatting, publishing, and submission building for US and global submissions
  • Ensures completion of high-quality submissions, adhering to regulatory guidelines, regional specifications, and company standards
  • Provide support for all upgrade activities for submission publishing tools and document management applications
  • Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation
  • Apply knowledge of electronic publishing requirements to ensure compliance with Health Authority submission specifications and remain current with evolving standards for global electronic submissions
  • Plan and publish regulatory submissions, ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
  • Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues.
  • Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
  • Propose new regional and global processes for paper and electronic submission publishing, including the evaluation of current processes.
  • Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites.
  • Review R&D documents to ensure compliance with company submission ready standards guidelines.
  • Contribute to new and updated processes and standards.
  • Participate in validation testing of new and upgraded software
  • Responsible for the accuracy of information for submission metrics and registration information for senior management.
 
QUALIFICATIONS:
  • Bachelor's degree preferred or equivalent related experience and education
  • 5-7 years Regulatory Operations experience
  • Experience with Regulatory formatting and publishing is required
  • Experience with electronic submission building tool (GlobalSubmit Publish, Liquent InSight Publisher, CSC eCTDXpress, Extedo eCTDmanager, etc.) is required
  • Experience with publishing and compiling initial applications (i.e. INDs, NDAs, BLAs, MAAs) from pre-planning phase to transmission of submission is strongly preferred
  • Experience using electronic document management systems is preferred
  • Strong attention to detail
  • Ability to solve problems under pressure and is able to effectively prioritize tasks
  • Must demonstrate critical thinking, risk assessment, and sound judgment
  • Works under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines
  • Excellent written and verbal communications skills
  • In-depth understanding of MS Word, Word templates, and standard Office tools
  • Extensive experience using Adobe Acrobat (including advanced Toolbox features)
 

Questions? Please contact Sara Finley via (925) 627-4917.
 
Ascent Life Sciences specializes in Medical Device, Pharmaceutical, Biotech, and clinical validation search for contract staffing, contract-to-hire, direct hire search and small project consulting services for FDA-regulated industries.
 
 
Job ID: 17-04618
Help us improve CareerBuilder by providing feedback about this job: Report this Job.
CAREERBUILDER TIP
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.