Pharmaceutical Regulatory Affairs Manager - CMC

Job Summary:

Responsible for timely preparation of high quality CMC sections for product registration documents filed with FDA and foreign regulatory agencies. Responsible for providing timely and accurate guidance to Product Development, Manufacturing, and Quality to ensure generation of adequate CMC data to meet registration requirements.

 

Essential Functions:

?  Responsible for review of CMC data and assembly of submission documentation new 

  drug products and medical devices.

?  Responsible for communication with FDA and/or other government agencies to

  resolve CMC issues.

?  Responsible for preparation of CMC sections of supplements and annual reports

?  Responsible for review and approval of SOPs, Master Batch Records, Raw Material 

  Specifications and Analytical Methods for new products.

?  Responsible for maintaining up-to-date knowledge of FDA regulations and guidance

  documents pertaining to CMC issues, and advising affected department heads of

  changes and trends.

?  Provide regulatory guidance and interpretation regarding CMC issues to affected

  department heads.

 

Additional Responsibilities:

?  Oversee assignment of product codes and UPC/Bar codes

?  Review product labels for compliance

 

Knowledge, Skills & Abilities:

Strong communication skills (verbal, written), ability to communicate across multiple disciplines successfully and accurately;  Attention to detail and accuracy; Flexible, ability to adapt to changing priorities;  Ability to understand scientific, manufacturing and quality control disciplines;  Knowledge of FDA regulations and guidelines, CDER;  Computer expertise in word processing, spreadsheets, and graphics packages;  Knowledge of DEA regulations; Knowledge of ICH regulations/guidelines

 

Education/Experience:

Requires a Bachelor?s degree in scientific discipline. Must have: 5+ years drug regulatory experience.