Summary:

Provides regulatory support to all preapproval and post approval activities for new products and existing products through product's lifecycle. Prepares and compiles drug product regulatory documents. Provides regulatory guidance to matters related to product development. 

Primary Functions:

1.    Coordinates activities in the preparation of Regulatory Drug Product Applications (i.e. ANDA, NDAs, Marketing Authorizations, Amendments, Annual Reports, Supplements, CMC Sections, etc.):

• Searches, retrieves and compiles all the necessary documentation for authoring of the applicable regulatory filing.
• Ensures technical accuracy and regulatory completeness of documentation to support drug product regulatory submissions. 
• Provides regulatory guidance to the chemistry, manufacturing and control sections of IND, NOA, ANDA; and supplemental filings, in line with previous development work. 

2.    Provides regulatory support and direction to all matters related to process development, ne product, and technology transfer by: 

• Reviewing technical information and reports in support of new products for accuracy a regulatory acceptability. 
• Advising clinical supply manufacturing and packaging activities.
• Coordinate shipping of clinical samples for bioequivalence studies.
• Monitoring the conduct and progress of clinical investigations.
• Review and approval of technical documents such as specifications, protocols and reports.

3.    Coordinates and oversees product post-approval activities:

• Searches, retrieves and compiles all the necessary documentation for authoring of the applicable post approval filling.
• Advises on CMC activities in support of post approval changes for new and existing products. 
• Evaluates change requests for regulatory acceptability to maintain drug approva1 conditions. 
• Coordinates and performs Drug Product Listing activities for new and revised products.