Regulatory Affairs Manager (Maplewood, MN)
Maplewood , Minnesota
January 05, 2017
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Job Description:

3M is seeking a Regulatory Affairs Manager for the Drug Delivery Systems Division located in Maplewood, MN.

Job Summary:
The Regulatory Affairs Manager will have global responsibility for development and execution of regulatory strategies for new products and marketed products for the Drug Delivery System Division.

Primary Responsibilities include but are not limited to the following:

Provide Regulatory options for Business Strategies for new drug development activities Use knowledge of regulatory paths to set direction for each program Assess ease of regulatory approval in various markets and help business prioritize market opportunities Identify risks and develop mitigation plans Interface with customer on registration activities Create new regulatory strategies to address 'new to the world' development programs

Determines Regulatory strategy for marketed products changes Implement changes efficiently while maintaining compliance to regulatory reporting requirements Provide regulatory strategy to customers Maintain site registrations and support inspections by regulatory agencies Provide regulatory decisions on compliance Champion new processes to meet compliance requirements

Provide Regulatory assessment for new partnership opportunities Identify strategic opportunities based on available regulatory paths Understand regulatory strategies of the competition

Stakeholder Management Integrate the needs of global business team into operational plans Provide guidance to Lab, Quality, Manufacturing on content of data packages Provide Regulatory opportunities for business Strategic Planning Engage Regulatory agencies on policy issues important to the business Participate in industry forums to maintain visibility of 3M capabilities Interact with other Health Care divisions within 3M to ensure alignment

Supervision Establish systems to ensure compliance of all 3M products to local laws & regulations as well as 3M internal policies Coordinate and align regulatory activities at each site Develop budget and resource plan to meet work load while maintaining stretch Conduct Health of the Organization planning for future business needs Identify and manage outside consultants as needed Coach and develop direct reports to reach fullest potential Maintain rigorous management of intellectual property & confidential information

Basic Qualifications:
  • Bachelor's degree or higher in Biology, Chemistry or Chemical Engineering from an accredited university
  • Minimum of three (3) years regulatory experience working with drug products.
Preferred Qualifications:
  • Minimum of five (5) years regulatory experience working with drug products
  • Understanding of quality systems requirements for drugs and drug/device combination products
  • Previous experience with inhalation or trans dermal products
  • Detailed oriented, ability to navigate matrix environment

Location: Maplewood, MN
Travel: May include up to 5% domestic and international
Relocation: Is not authorized

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Innovation is a way of life at 3M. We solve problems by applying creativity, team work and ingenuity to improve life for millions of people worldwide.

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