Associate Director/ Director of Regulatory Affairs Associate Director/ Director of Regulatory Affairs …

Hamlyn Williams
in Seattle, WA, United States
Permanent, Full time
Be the first to apply
Competitive
Hamlyn Williams
in Seattle, WA, United States
Permanent, Full time
Be the first to apply
Competitive
Associate Director/ Director of Regulatory Affairs
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
Hamlyn Williams logo
More Jobs Like This
See more jobs
Close
Loading...
Loading...