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Job

Associate Director/ Director of Regulatory Affairs

  • Location

    Seattle

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Jessica Figueroa

  • Contact email:

    j.figueroa@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 months ago

  • Expiry date:

    2021-08-31

  • Startdate:

    ASAP

Description:

A commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. This Company has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. This Company also has a diverse group of preclinical programs, a novel target in immuno-oncology that modulates a new cancer immunity axis discovered recently. 

Job Responsibilities: 

  • Advising on the context and applicability of global and national regulatory requirements for development programs appropriate to the stage of product development
  • Providing leadership and mentoring to department staff with emphasis on development and integration of regulatory plans and strategies for products in early development through post- commercialization
  • Serving as the regulatory representative at project meetings and interacting with cross- functional team to achieve common goals
  • Being the lead author on key regulatory submissions (e.g., briefing documents, applications for expedited programs)
  • Developing a regulatory strategy for assigned development programs in conjunction with the cross-functional team
  • Interacting with domestic and foreign regulatory agencies on assigned projects
  • Preparing cross-functional teams for regulatory interactions
  • Providing strategic direction for regulatory submissions
  • Ensuring content and accuracy of regulatory submissions for assigned development programs
  • Negotiating, interacting with, and supervising the regulatory activities of contract research organizations in the preparation of regulatory submissions for assigned development programs

Education, Experience, Skills, and Knowledge Required:

  • A BS degree and a minimum of 7 years of related experience in the pharmaceutical industry for a Sr. Manager level and a minimum 10 years of experience in the pharmaceutical industry for an Associate Director level
  • Experience in oversight and management of development programs
  • Direct experience in interacting with regulatory authorities and preparing cross-functional teams for such interactions
  • Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
  • Excellent teamwork and collaboration capabilities
  • Knowledge of the drug development process and global regulatory guidelines
  • Display strong analytical and problem-solving skills

Other Requirements:

  • Some periods (e.g., major submissions) may require workdays longer than 8 hours
  • Occasionally, work with international vendors may require being available outside of core working hours
  • Occasional overnight and/or international travel

I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Jessica Figueroa 619-326-3672 or j.figueroa@hamlynwilliams.com