Associate Director, Regulatory Affairs – CMC                         

Reports to:  Senior Director, Regulatory Affairs – CMC

I.                   Purpose of Position: 

The incumbent develops, communicates and implements CMC-related regulatory strategies consistent with US/Canadian product development, registration and commercial objectives

II.            General Functions/Specific Responsibilities:

1.      Develops and implements CMC regulatory strategies to facilitate the progress of drug development.

2.      Organizes and manages regulatory aspects of product development programs.

3.      Serves as regulatory representative for select product development programs, including regulatory liaison with the FDA and other regulatory agencies, as assigned.

4.      Manages, prepares and ensures the timely completion of well-organized, scientifically sound CMC-related regulatory submissions (domestic and international), to include INDs, CTAs, DMFs, etc. and required amendments that comply with applicable regulatory requirements.

5.      Reviews technical reports and summary documents (chemistry, manufacturing and analytical controls) for adherence to regulatory guidelines, strategies, and commitments.

6.      Evaluates and prospectively resolves issues that impact the quality of CMC submissions.

7.      Provides regulatory guidance on CMC requirements and provides regulatory risk assessments and intelligence on CMC-related regulatory issues.

8.      Evaluates and Oversees the preparation and submission of timely responses of Health Authority questions.

9.      Represents the company at FDA meetings. Leads interactions and negotiations with FDA on CMC issues.

10.  Ensures timely and effective regulatory input on Change Control proposals.

11.  Recommends regulatory policies to assure adherence to FDA requirements. Contributes to the modification, development and implementation of company practices and policies for regulatory affairs.

12.  Communicates the impact of new regulations on company products.

13.  Prepares appropriate Regulatory Standard Operating Procedures and provides regulatory review of SOPs from other departments, as necessary.

III.            Relationships:

1.      Internal:       VP Corporate QA, Director, Supply Chain Management, Manufacturing Site Directors, Pharmaceutical R&D Directors, Contributors to Regulatory Submissions

2.      External:              FDA, Partner-Company Counterparts, Suppliers

IV.            Requirements for Position:

1.      Knowledge:  Chemistry, analytical and pharmaceutical technology and regulations governing drug development and post-approval changes.

2.      Education:  BS in Chemistry or Pharmacy degree, advanced degree (MS/PharmD or PhD) preferred

3.      Experience: 15-20 years of experience in the pharmaceutical/biotech industry and minimum of 10 years of hands-on Regulatory CMC experience. 

V.            Supervision:

1.      Directly Supervises:  One or more Regulatory Affairs personnel

2.      Indirectly Supervises:  None

VI.            Responsibility: 

Acting as the regulatory representative on core teams, developing and planning regulatory submission strategy, coordinating the preparation of submissions to regulatory agencies, coordinating adverse event reporting, and conducting regulatory intelligence activities.

VII.            Contacts:

VIII.            Confidential Data: Proprietary Product Information

IX.                  Working Conditions:  Office Environment