Awarded the Deloitte Touche Technology Fast 500 Award as one of the fastest growing companies in North America in 2010, Lannett is the fast-forward leader in the manufacture of generic pharmaceuticals as well as being a one-stop, blend to bottle manufacturer.
Lannett Company, Inc. is seeking a highly talented and self- motivated professional to join our team as a Regulatory Affairs Associate in our Regulatory Affairs Department.
We are seeking a detail oriented person that is ready to prepare and review regulatory documents for submission to FDA. Our Regulatory Affairs professionals are involved in the entire filing process and have a broad knowledge of all parts of that process.
We are looking for an associate to prepare and review the following documents prior to submission to the FDA:
• New Drug Applications (NDAs)
• Abbreviated New Drug Applications (ANDAs)
• Adverse Experience Reports
• Annual Reports
• Drug Master Files
• Labeling (pre- and post-approval)
• Other regulatory and GMP documents
As a Regulatory Affairs Associate, you will share your knowledge and experience and provide guidance to others in a professional team environment.
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 3-5 years in Regulatory Affairs.
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. Relocation expenses will not be covered. Candidates must be able to pass a company paid background check and drug test..
Lannett Company, Inc. is an Equal Opportunity Employer M/F/D/V.
To apply for this position please follow the link below: