For The Candidates

Ra Mgr - Regulatory Affairs Manager Generic
IL
Type: Full-Time
Category: Regulatory Affairs
Job ID: 756
Opportunity Description:

(847) Area Code                Chicago Area                        65-75k

 

Regulatory Affairs Manager

 

Responsibilities:

 

            Responsible for all activities of the Regulatory Affairs Department.  Main objectives are to file and obtain ANDA approvals and to ensure compliance with FDA regulations.

 

Typical Duties:

 

            1.  Submits quality submissions of ANDAs, AADAs, Supplements and Amendments in a timely manner.

            2.      Reviews and submits Annual Reports, Periodic Reports, Annual Drug Reviews, Adverse Drug Experiences and Recall Coordination Activities.

            3.      Our contact person with Project Managers at FDA-CDER.

            4.      Participates in product review meetings, evaluates project priorities and coordinates activities to facilitate timely procurement, compilation, review and submission of ANDA’s and Supplements; Monitors review and approvals.

            5.      Interfaces with QC/QA, R&D, Marketing and Manufacturing in data generation and strategy development.

            6.      Provides regulatory/technical input for product development and reformulation.

            7.      Interprets regulations and provides consultancy for compliance needs.

            8.      Provides answers to Marketing inquiries.

            9.      Supervises staff and assists in their professional development, performance evaluation and salary administration.

 

Job Specifications:

 

            ·      Advanced degree in a scientific/technical discipline

            ·      Five to seven years of pharmaceutical industry experience and a minimum of three to five years FDA submission experience.

 
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