Nesher Pharmaceuticals (USA) LLC
  • 06-Feb-2018 to 07-Apr-2018 (CST)
  • Regulatory Affairs
  • St. Louis, MO, USA
  • Full Time

Competitive Benefits Package


summary

Assist in the necessary activities directed toward generating the required elements for FDA drug product regulatory submissions to FDA, including the generation of information requested by FDA, through the regulatory review process of drug product applications. Assist in all Regulatory Affairs department activities, including electronic publishing, regulatory intelligence, product labeling updates, and adverse event processing. Represent the Regulatory Affairs department in cross-functional initiatives, as necessary.

 

essential Duties and Responsibilities

Regulatory Submission and Support

  • Assist in the review and approval (as required) of regulatory submission documents for regulatory acceptability.
  • Assist in the compilation of the necessary documentation for chemistry, manufacturing, and controls (CMC) and bioequivalence (BE) / bioavailability (BA) documents to the FDA.
  • Prepare CMC data sections for new product applications, amendments and supplemental submissions, as directed.
  • Assist marketed product support by providing insight into drug product approval conditions for post-approval activities.
  • With supervisor guidance, may serve as the regulatory representative on new product and/or marketed product support cross-functional teams through the development lifecycle of submitted products.
  • With supervisor guidance, may interact with Regulatory agencies for routine items.
  • Assist Regulatory management in the creation of project timelines for one or more projects.
  • Assist Regulatory management in working with outside vendors and/or Zydus India on the preparation of the clinical sections of original drug product applications and supplemental submissions.
  • Assist in activities leading to responses to FDA deficiency letters and information requests for regulatory submissions.

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

  • Publish product submissions in the electronic publishing system or work with external ePublishing vendors to complete electronic publishing of product applications.
  • Assist in tracking and communicating electronic submission requirements (FDA/ICH).
  • Assist in the development and maintenance of submission standards and templates.
  • Assist in the adverse event processing system and the submission of adverse event reports to regulatory authorities.
  • Create, review, and approve product labeling to identify appropriate content and format of required product information, as directed.
  • Assist in the review and approval of revisions to approved drug product labeling.
  • Assist in the review and approval of clinical trial and development batch labeling for accuracy and required information.General
  •  
    • Assist in archiving and maintenance of product submissions and FDA correspondence, including but not limited to, submissions documents, adverse event correspondence and departmental labeling review files, per applicable departmental/company SOPs.
    • Take on assignments with increasing complexity.
    • Assist in change control review on routine items for regulatory impact as requested.
    • Assist in the development of departmental SOPs as required.
  • Provide support during FDA pre-approval inspections as necessary.
  • 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

    • Knowledge of and ability to apply regulatory regulations.
    • Leadership skills to coordinate and provide guidance to all levels of personnel.
    • Excellent writing skills.
  • PC proficiency using Microsoft Office suite.

 

  • Project management skills.
  • Excellent communication skills and ability to effectively interact with many departments.
  • Flexible, with ability to handle and coordinate multiple projects in a dynamic, fast-paced environment.
  •  

EDUCATION/EXPERIENCE

  • Bachelor's degree in the sciences preferred or equivalent combination of Bachelor's degree and pertinent experience in pharmaceutical or other highly regulated industry.
  • Minimum one year experience in the pharmaceutical industry.
  • Minimum two years' actual regulatory experience with relevant dosage form products.
  • Good working knowledge and experience in the application of FDA regulations and guidelines as they pertain to product development and submissions. International regulatory experience is acceptable.
  • Prior experience in dealing with regulatory agencies preferred.
  • Experience with CTD format highly desired.
  • Experience with electronic submissions and/or content management systems preferred.

 

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 required to:

  1. Stand, walk, sit, reach, talk, and hear.
  2. 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.
  3. Exert an amount of force continuously and/or up to 5 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.
  2. Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
  3. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.
Nesher Pharmaceuticals (USA) LLC
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