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Job

Director Regulatory Affairs

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Fahd Joudi

  • Contact email:

    f.joudi@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    3 months ago

  • Expiry date:

    2023-03-20

  • Startdate:

    ASAP

Director Global Regulatory Affairs (biologics)

Job Purpose:

The Director Regulatory Affairs will serve as the Global Regulatory Lead (GRL) for one or more development programs. The successful candidate will have primary responsibility for developing global regulatory strategies and implementing regulatory activities and submissions in line with program goals and objectives. This position represents the regulatory function on cross-functional teams and serves as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development and registration activities. Experience with European regulations and interactions is required and will be a primary responsibility for this role.

  • Reports into the VP of GRA
  • Associate Director flexibility (reporting into the Director)
  • REMOTE (can also be residing in Europe)

Accountabilities:

  • Develop and implement regulatory strategy and submission plans to support global pivotal clinical trials including regulatory authority meetings, INDs, CTAs, and marketing applications worldwide
  • Conduct regulatory review of documents for health authority submissions 
  • Represent the regulatory function on cross-functional teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy 
  • Provide regulatory guidance and strategy including identifying and assessing regulatory risks 
  • Serve as point of contact with regulatory authorities, as applicable 
  • Monitor and research regulatory intelligence, to bring innovative approaches to the cross‑functional team and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on development plans 
  • Collaborate with global development partners 

Ideal Background:

  • Advanced degree or equivalent education/degree in life science/healthcare is preferred.
  • MS/PhD/PharmD in a scientific discipline with >4 yrs (AD) or > 6 yrs (Director) years of experience in Regulatory Affairs
  • Oncology experience highly desirable
  • Knowledge and understanding of global regulations and guidelines
  • Previous experience in the preparation and submission of regulatory documents
  • Previous experience leading a team to prepare for and carry out major health authority interactions
  • Experience with investigational drugs, including those in late-stage development
  • Ability to work in a cross-functional team environment
  • Strong attention to detail and the ability to handle multiple tasks
  • Excellent organizational, computer and documentation skills and an ability to prioritize effectively
  • Strong interpersonal skills including verbal and written communication

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