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Ra Assoc. Director/ Director - ANDA - Regulatory Affairs- Generic
NJ
Type: Full-Time
Category: Regulatory Affairs
Job ID: 744
Opportunity Description:
(908) Area code                                                                         Northern NJ Area
 
 
 

Director, Regulatory Affairs

A leader in the development, manufacture and sales of first-class generic pharmaceuticals with operations in 32 countries, products registered in more than 60 countries, a robust development pipeline and an aggressive acquisition strategy.

Qualifications:

  • Provide mentorship, growth potential and ensure that the entire staff receives periodic training and guidance for regulatory submissions and FDA regulations.
  • Direct even workflow distribution to staff members to ensure timely filings
  • Support the facility and 3rd Party businesses by providing regulatory advice in connection with product selection, ANDA filings, and post-approval changes.
  • Maintain clear communications with FDA regarding review status inquiries, resolving deficiency issues, seeking regulatory guidance and other related matter

          Staff management:

Direct a staff of Sr. Associate(s) and Associates towards fulfilling regulatory functions supporting the facility and 3rd Party businesses. Provide mentorship, growth potential and ensure that the entire staff receives periodic training and guidance for regulatory submissions and FDA regulations. Direct even workflow distribution to staff members.

 

            Regulatory support:

Provide regulatory guidance to the various functional groups in connection with remediation of  products, new product selection and in-licensing, ANDA filings, post approval changes.

 

            Communications:

Maintain clear communications with FDA regarding review status inquiries, resolving deficiency issues, seeking regulatory guidance and other related matter.  Communicate routinely with the Regulatory Affairs Directors for the other locations to ensure consistent regulatory advice is offered across all US sites.

 

            Continuous improvement:

Continuously improve upon all types of submission template and content to make the submissions reviewer friendly and there by reducing the overall review cycle time at the Agency. Enhance our image by making high quality submissions and accepting new challenges in changing era of Regulatory Submissions (e.g. eANDAs).

Requirements; 

  • BS Degree in scientific discipline, preferably Chemistry, Biology, or Pharmacy.
  • Masters Degree Preferred
  • 10+ Years in a Pharmaceutical Regulatory managerial or related role
  • Experience in aspects of the sales and marketing of pharmaceuticals, including issues relating to FDA pharmaceutical regulations, advertising, product development, product labeling, promotional review, antitrust, anti-kickback and compliance issues, regulatory policy, and contracts
  • Leadership qualities, diplomacy, ability to enforce difficult positions, excellent communication skills
 
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