Associate Director, Regulatory Operations (Remote Position)

Location
Working from Home
Posted
May 14, 2022
Ref
4458553004
Required Education
Bachelors Degree
Position Type
Full time

ASSOCIATE DIRECTOR, REGULATORY OPERATIONS (Remote Position)

The Associate Director of Regulatory Operations will report to the Executive Director, Regulatory Affairs and will provide leadership on regulatory operations activities for Global Blood Therapeutics, Inc. (GBT).  This position will support day-to-day regulatory operations activities of assigned projects. These include providing publishing support, systems ownership, managing workflow timelines and outsourcing of publishing activities when needed.  Option to work remotely with occasional travel to South San Francisco will be required.

Essential Duties and Responsibilities:

  • Lead the Regulatory Operations Team to plan, prioritize, prepare, and submit documents to the FDA and ex-US health authorities using both paper and electronic publishing tools. This includes formatting of Word documents, converting to PDF and finalizing the document preparation
  • For complex submissions, track and manage workflow timelines internally with colleagues
  • Facilitate the internal review and approval process for regulatory submissions
  • Assist in the development and maintenance of processes and standards relating to regulatory submissions
  • Internal point of contact for submissions.  Back-up to filing correspondence and assisting with EDMS and Word template support

Qualifications:

  • 7-11+ years eSubmission working experience with eCTD tools, the FDA and EMA
  • 3+ years of experience leading teams and/or managing people (i.e., employees, contractors)
  • Expert technical knowledge and working skills of computer software including advanced MS Word and Adobe Acrobat Pro features and functionality
  • Expert use of PDF publishing plug-in tools such as ACUTA PDF Tools or ISI Toolbox
  • Experience with eCTD publishing software (e.g., eCTD Xpress, InSight Publisher, Extedo, ACUTA, etc.) and with electronic document management systems (e.g., SharePoint, Livelink, etc.) required
  • Superior organization skills and attention to detail are mandatory
  • Proficient knowledge of ICH Common Technical Document (CTD) specifications and other regulations and guidance documents associated with electronic submissions

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.