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Sr. Manager, Regulatory Affairs
Summary:
Assures that marketed products are maintained in line with the current regulatory requirements and registered information for targeted countries. Obtains expedient registration of changes necessary to bring products into compliance in a cost effective manner. Develops and implements systems and processes to insure products remain in compliance with applicable regulations.

Major Duties and Responsibilities:

  1. Assesses global regulatory risk to currently marketed products and recommends remediation, as necessary, to bring products into compliance globally.

  2. Advises programs on regulatory requirements, coordinates and presents regulatory data needs, and negotiates with and influences management, colleagues and partners to ensure regulatory data requirements are met.

  3. Defines and implements regulatory strategies and priorities. Proposes new/revised processes and recommends standard interpretation of regulations.

  4. Manages the preparation and review of registration packages to ensure effective data presentation and quality.

  5. Maintains an awareness of legislation and assesses its impact on the regulatory status of currently marketed products. Creates systems to assure regulatory compliance, and strives to maintain products remain in compliance.

  6. Manages the processes to achieve regulatory agency input into plant and operations programs. Requests, manage and facilitate agency meetings.
Requirements:
A Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related.  Master's degree and/or PhD preferred.  Eight years experience in the Pharmaceutical industry - Quality Assurance, Compliance or R&D.  A minimum of three years in regulatory affairs.  Experience working directly with regulatory agencies.  Sound knowledge of applicable portions of agency guidances and regulations for pharmaceutical products.  Ability to challenge scientific arguments.  Good oral and written communication skills.
United States
Illinois
USA - IL - Lake County
Full Time
First or Day
11035BR
Salaried