Regulatory Affairs Assocaite I

Regulartory Affairs Philadelphia, Pennsylvania


Description

We are seeking a detail oriented person that is ready to assist Regulatory Affairs Management in the preparation, review and submission of applications to the Food and Drug Administration (FDA), as well as have responsibility over the review and approval of GMP documents.

 

We are looking for an associate to:

  • Prepare supplemental applications for review by company management and submissions to the FDA
  • Prepare Annual Reports for review by company management and submission to the FDA
  • Prepare Periodic Adverse Drug Experience Reports for review by company management and submission to the FDA
  • Prepare and/or review documents for inclusion in regulatory submissions
  • Review controlled documents for comformance to regulatory requirements, including protocols, reports, batch records, and packaging orders
  • Assist in other regulatory tasks, as needed.

 

Detail oriented; thoroughly review documentation for accuracy and completeness.  Cooperate and communicate with multiple departments to coordinate the collection of data. 

 

Must be highly organized.  Ability to locate and interpret current government regulations and guidances.  Ability to read, analyze and interpret technical documents.  Excellent project management skills.  Ability to work well in a multi-disciplined environment.  Proficient in MS Office products, especially Word, Outlook and Excel.  Bachelor’s Degree in Science, preferably in Chemistry or Pharmacy with pharmaceutical solid dose industry experience with a minimum of one to two years of experience in Regulatory Affairs in the pharmaceutical industry.

 

We offer a comprehensive benefits package, including medical, vision, dental, and prescription plans; immediate eligibility in the 401(k) plan with company match; PTO; Employee Stock Purchase Plan, and tuition reimbursement.

 

Please include your salary requirements in order to be considered. Candidates must possess authorization to work permanently in the United States. Candidates must be able to pass a company paid background check and post offer drug screen.


Lannett Company, Inc. is an Equal Opportunity Employer M/F/D/V.