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.
Posted On -
2/19/2013 7:19:07 AM
Required Skills and Experience:
* Auditor certification for GMP/pharmaceutical industry is strongly preferred.
* Experience auditing in a pharmaceutical environment.
* Good Documentation Practices
* Demonstrated proficiency in MS Word, Excel, Access, PowerPoint and Windows.
* Experience with cGMP’s, FDA Regulations, FDA Guidances and other international regulatory agency regulations.
* Experience with supply and/or quality agreements a plus.
* Knowledge of statistics, QbD, DOE and other improvement techniques a plus.
Qualifications: This position requires excellent verbal and good written communication skills and the ability to prioritize and organize multiple tasks simultaneously. Must be organized and detail-oriented. Must have a strong customer service attitude and a professional demeanor when dealing with internal and external clients. Requires strong interpersonal skills to interact with diverse groups of individuals. Ability to maintain confidential information. Ability to handle multiple tasks and projects. Must demonstrate dependability and reliability.
Include salary requirements to be considered. We offer a comprehensive benefit package, including medical, vision, dental, and prescription, immediate eligibility in the 401(k) plan with generous company match, Employee Stock Purchase Plan, and tuition reimbursement. Individual contributors only. No recruiters. Lannett Company, Inc. is an Equal Opportunity Employer. Located in Northeast Philadelphia. Local candidates only. Must submit to and pass a company paid background check and pre-employment drug test.
Posted On -
2/19/2013 7:16:06 AM
• Thorough knowledge of common laboratory test procedures and instrumentation, especially HPLC; USP/NF methodology; relevant regulatory requirements. Good knowledge of non-routine tests and scientific concepts.
• Strong knowledge of method development and validation.
• Ability to read and interpret test procedures, manuals, technical documents or instructions in mathematical or diagram form, SOPs and governmental regulations. Ability to summarize and explain such documents to more junior and senior staff.
• Ability to apply concepts such as fractions, percentages, ratios, proportions, and statistics to practical situations.
• Ability to perform mathematical calculations used for assigned testing and to assist more junior staff in performing calculations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to report data and observations accurately, both in writing and verbally.
Educational Requirements and/or Work Experience:
Bachelor’s degree in chemistry or related discipline or equivalent combination of education and work experience; for example bachelor’s degree plus 4-8 years relevant experience. Master’s degree desirable.
Submit your salary requirements. We offer a comprehensive benefit package, including medical, vision, dental, and prescription, immediate eligibility in the 401(k) plan with generous company match, Employee Stock Purchase Plan, and tuition reimbursement. Individual contributors only - no recruiters. Lannett Company, Inc. is an Equal Opportunity Employer. Located in Northeast Philadelphia - local candidates only as no relocation assistance is provided. Must submit to and pass a company paid background check and pre-employment drug test.
Posted On -
2/19/2013 7:13:14 AM