Senior Regulatoy Affairs Associate

Regulartory Affairs Philadelphia, Pennsylvania


Description

Lannett Company, Inc. is seeking a highly talented, detail oriented, and self-motivated professional to join our team as a Senior Associate in the Regulatory Affairs department.

The candidate will be expected to independently prepare and review many types of documents for submission to the FDA, including the following (not an all-inclusive list), in a format compliant with FDA standards. In addition, the candidate will be expected to communicate with FDA and represent the Regulatory Affairs department in cross functional team meetings and must possess a strong understanding of regulations and guidances. The applicant will assist in determining regulatory strategy for new submissions and post-approval changes. The applicant will also be required to review controlled documents for conformance to regulatory requirements. The Senior Regulatory Affairs Associate will be expected to share their knowledge and experience and provide guidance to other associates and coworkers. Additional types of assignments may be given, as needed.

  • New Drug Applications

  • Abbreviated New Drug Applications

  • Supplemental Applications

  • Amendments

  • Annual Reports

  • Adverse Experience Reports

     

The ideal candidate must have experience with thoroughly reviewing documentation for accuracy and completeness, successfully communicating with FDA and other stakeholders (internal and external), and providing guidance to other associates. The candidate must have the ability to work independently and manage/prioritize projects to ensure targeted timelines are met.  

Background requirements:

  • A minimum of 5 years’ experience in Regulatory Affairs with a generics company is preferred

  • A minimum of a Bachelor’s degree, preferably in Chemistry or a related, scientific discipline

  • Experience with Adobe Acrobat and Windows-based programs such as Microsoft Word, Excel, and SharePoint is required

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. Seeking local candidates from the Philadelphia area only-no relocation provided. Candidates must be able to pass a company paid background check.

 

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