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Job

Manager/Senior Manager Regulatory Operations

  • Location

    Princeton, NJ

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    28 days ago

  • Expiry date:

    2021-08-31

  • Startdate:

    ASAP

Job Title: Manager/Senior Manager Regulatory Operations

Location: 2-3 days a week in Princeton, NJ office

Direct Reports : Yes

Department: Regulatory Science

Job Summary:

Manages and coordinates the timely, compliant and accurate delivery of dossiers to health authorities. Provides support to define and implement regulatory operation processes and standards. Supports the implementation and maintenance of regulatory information management system (RIMS). and RIMs training.

 

Essential Job Functions:

• Drives the execution of eCTD content plans through collaboration with cross functional team members

• Acts as liaison while coordinating regulatory publishing activities for submissions

• Creates and implements processes to maximize electronic lifecycle /submission requirements, including a focus on continuous improvements

• Provides direction to staff and contingent workers to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards

• Develops, trains, and maintains regulatory operations work instructions

• Provides regulatory publishing guidance to other departments / functions

• Contributing member in regulatory submission team meetings

• Evaluates emerging regulations for impact on regulatory operations and systems

• Leads projects and other quality improvement projects for regulatory operations

• Contribute to the development and implementation of standards and procedures related to of eCTDs

• Other miscellaneous regulatory operational activities.

 

Job Requirements:

• Knowledge of FDA/EMA/regulations and guidance for electronic submissions

• Excellent knowledge and experience in regulatory operations, including: formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences

• Demonstrated performance in managing and producing time-intensive deliverables

• Expert knowledge of Document Management Systems (Veeva preferred) and publishing tools (e.g., Veeva publishing, Omnisha, and ISIToolbox)

• Demonstrated experience in Microsoft Office suite and SharePoint

• Knowledge in developing processes for publishing activities in support of RIMs use

• Exhibit strong attention to detail, good organization, communication, and collaboration skills

• Seamless multi-tasking abilities to be able to work simultaneously on multiple projects

 

Experience / Education

• Bachelors degree in Life Science, Computer Science or other related discipline

• 5 years’ experience in Regulatory Operations (US/EU) with eCTD regulatory submission responsibility

• Experience in Regulatory Operations and managing personnel

• Expert in eCTD structure and requirements for US/EU and experienced with guidelines related to regulatory submissions

• Knowledge of drug development process

• Experienced with electronic document management systems and publishing tools (Veeva preferred)

 

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