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Associate Director, RA Strategy

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Associate Director, RA Strategy

  • Location:

    Boston, United States

  • Sector:

    Life Sciences

  • Contact:

    Christine Weigel

  • Job ref:

    513

  • Published:

    3 months ago

  • Expiry date:

    2020-11-23

The Associate Director, Regulatory Affairs will play a key role in the development and implementation of Regulatory strategy leading to successful registration and life-cycle management of products. S/he will serve as the Regulatory Lead for the US on relevant projects and as our portfolio expands, may also serve as Global Regulatory Lead and work with the European counterpart, located in Germany. This position reports to the VP, Head of Regulatory Affairs US and will be located in our Boston, MA office.
 
Principal Responsibilities:
  • Develops and implements effective regulatory strategies to support projects from MorphoSys portfolio to ensure successful registration and life-cycle management
  • Represents MorphoSys as point of contact with regulatory authorities, including providing support and coordination of regulatory meetings and respective briefing packages development
  • Provides advice on regulatory issues for both marketed and development products; actively collaborates with cross-functional colleagues (e.g., commercial, clinical development, biostatistics, medical affairs, legal, manufacturing, quality)
  • Prepares and executes region-specific aspects of regulatory affairs, and ensures integration into global regulatory strategy
  • May serve as Global Regulatory Lead on assigned programs
  • As GRL, acts as primary regulatory contact for associated Global Development Team and leads regulatory sub-team for the program
  • Coordinates submissions to regulatory authorities in support of proposed and ongoing development programs, (e.g., new clinical trial submissions, new marketing authorization applications)
  • Monitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs
  • Supports the regulatory activities to ensure an efficient implementation of the regulatory strategy for the US affiliate for existing pipeline assets and commercial products
  • Develop and maintain adequate processes and SOPs to ensure regulatory compliance
Job Qualifications, Experience & Skills
Skills and Education:

Education

Bachelor’s degree required; a scientific discipline is strongly preferred
Advanced degree highly preferred

Experience and Skills
  • 7+ years of experience with FDA regulatory activities and processes
  • Experience in oncology, immunology and/or orphan/rare diseases is highly desirable
  • Demonstrated strong knowledge of drug development and regulatory policies combined with a solid scientific and business judgment
  • Manages complex issues and coordinates multiple projects simultaneously
  • Exhibits exemplary behavior, ethics and transparency within the company and with the authorities
  • Demonstrated ability to lead without authority
  • Works collaboratively in multi-functional teams as a key player with strong interpersonal and communication skills
  • Strong attention to detail, well organized, scientifically driven, pragmatic and open-minded (willing and able to consider new and effective ways of doing work)