Nesher Pharmaceuticals (USA) LLC
  • 04-Apr-2018 to 03-Jun-2018 (CST)
  • Regulatory Affairs
  • St. Louis, MO, USA
  • Full Time

Competitive Benefits Package


summary

Manage the necessary activities directed towards generating the required elements for FDA drug product regulatory submissions to the FDA. Manage the compilation of documentation for regulatory submission as well as all activities leading up to the generation of information requested by the FDA throughout the regulatory review process of drug product applications. Align with departmental goals, objectives and metrics. Represent the Regulatory Affairs department in Company cross-functional initiatives as necessary. Ensure the integrity and accuracy of labeling for all finished drug products manufactured and distributed by the Company and its subsidiaries are in compliance with all applicable regulations and Company SOPs. Manage the adverse event process and submission of adverse events to regulatory authorities.

 

essential Duties and Responsibilities

Regulatory Submissions and Support

  • Manage, review and approve contents of submission components and assess the adequacy in direct comparison with appropriate regulations and guidelines.
  • Lead activities with other departments (i.e., R&D, QA/QC, Operations, etc.) to provide the regulatory requirements needed to obtain submission-ready documents to file original submissions, amendments and post-approval supplements.
  • Manage the compilation and preparation of product applications.
  • Manage and prepare CMC data sections for original drug product applications and supplemental submissions.
  • Work with outside vendors and/or Zydus India on the preparation of the clinical sections of original drug product applications and supplemental submissions.
  • Manage the multidisciplinary reviews and approvals for regulatory submission documents.
  • Manage activities leading to responses to FDA deficiency letters and information requests for regulatory submissions.
  • Manage interactions with contracted RA resources and consultants, as appropriate.
  • Prepare and manage the submission of annual reports.
  • Assess marketed product support by providing insight into drug product approval conditions for post-approval activities.
  • Provide regulatory guidance and support for contract manufacturing projects.
  • Prepare regulatory assessments of key issues with potential for regulatory application actions.
  • Maintain submission action plans and document tracking for drug product submissions and follow up with internal and external clients as appropriate.

Regulatory Operations (Electronic Publishing (ePublishing), Adverse Events, Labeling):

  • Prepare product submissions on electronic publishing system or work with ePublishing vendor to complete electronic publishing of product applications.
  • Define and communicate electronic submission requirements (FDA/ICH).
  • Ensure electronic submissions are complete and in accordance with FDA/ICH guidelines.
  • Manage the development and maintenance of submission standards.
  • Perform review of change control items for regulatory impact.
  • Manage the adverse event processing system and the submission of adverse event reports to regulatory authorities.
  • Manage the creation, review, and approval of product labeling to identify appropriate content and format of required product information for new and marketed products as well as clinical trial and development labeling.

General

    • Provide comprehensive formal and informal leadership to direct reports and Company as a whole to promote a positive work environment and communicate overall business expectations to working groups.
    • Manage the archiving and maintenance of product submissions and FDA correspondence, including but not limited to, submission documents, adverse event correspondence, and departmental labeling review files, per applicable departmental/company SOPs.
    • Proactively identify project needs with minimal direction from management.Take on assignments with increasing complexity.
    • Involved in or may initiate interactions and communications with regulatory agencies in response to queries from regulatory agencies. Coordinate and support immediate supervisor for Agency meetings and teleconferences with regulatory agencies.
    • Manage the creation of project timelines for one or more projects.
    • Write departmental SOPs as required.
    • Serve as regulatory representative for new product and/or marketed product support cross-functional teams through the development lifecycle of submitted products.
    • Represent Regulatory Affairs on project teams and provides regulatory guidance in accordance with project team requirements.
    • Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
  • Provide regulatory support during FDA inspections, as required.

 

  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
  • Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

  • Comprehensive knowledge and experience in application of CMC/labeling regulations and guidelines.
  • PC proficiency using Microsoft Office suite.
  • Excellent writing skills and exceptional proofreading skills with attention to detail.
  • Able to handle multiple projects simultaneously while meeting tight deadlines.
  • Excellent communication skills and ability to interact effectively with cross-functional teams.

 

EDUCATION/EXPERIENCE

  • Bachelor's degree with a minimum of seven years' experience working in the pharmaceutical industry, with at least six of those years in regulatory submissions; or Master's degree or higher with five years' experience in the pharmaceutical industry, with at least four of those years in regulatory submissions.
  • Proven leadership qualities to mentor, coach, train and develop others.
  • Proven experience managing projects and/or people.
  • Experience working with regulatory agencies.
  • Experience using CTD/eCTD format.
  • Experience using electronic submissions and/or content management systems.
  • Experience using adverse event reporting a plus.
  •  

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is:

  1. Frequently required to sit and/or stand, walk, talk and hear.
  2. Constantly required to use hands and fingers to operate office machines and equipment.
  3. Frequently required to reach with hands and arms.
  4. Occasionally required to stoop, kneel and crouch.
  5. Required to have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
  6. Required to exert a negligible amount of force continuously and/or up to five pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

 

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job.

  1. Normal office conditions.

 

Personal Protective Equipment is required to be worn if assigned to perform work or tasks in specific production areas.

  • Eye protection (safety glasses).
  • Foot Protection (steel or composite toe safety shoes).
Nesher Pharmaceuticals (USA) LLC
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