Senior Manager, Regulatory Affairs (Remote)

SENIOR MANAGER, REGULATORY OPERATIONS (Remote)

Position Summary:

This role will be integral to the day-to-day functions and overall development of the Regulatory team.  The incumbent’s mains responsibilities will be to provide publishing support for GBT filings (US & RoW) and to provide archiving/records support for GBT’s EDMS.  In addition, they will also function as a representative of the Regulatory Operations overall group in interactions with groups outside of Regulatory, and even outside of GBT. This position will be an individual contributor role, and report to the Associate Director of Regulatory Operations.

Essential Duties and Responsibilities:

• Leading and supporting the filing of INDs and Marketed Products, including the formatting, PDF publishing, XML building of electronic submissions in eCTD
• Accountable for routine submissions to maintain the application, including:  Promotional 2253s, Safeties, Investigator 1572s, Annual Reports, Administrative Updates
• Clearly communicating expectations and the timing of deliverables, both within the regulatory group and with program management
• Manage the review process of reports (from Authoring to Approval) on the EDMS system
• Support the archival of agency correspondences, submission sequences, and other regulatory documents onto the EDMS system
• Train users with the authoring template on MS Word, and with EDMS usage
• Familiar with US, CA, and EMA template and publishing standards
• Can coordinate workload and be a point-of-contact for outside consultants or third-party publishers

Qualifications:

• Must have a BA or BS
• 6-9+ years of combined publishing/formatting/archiving experience
• Experience managing teams and providing guidance to team members
• Submission Management experience for a minimum of at least 1 US and/or Global IND and 1 NDA/BLA
• Excellent verbal and written communication
• Can manage & troubleshoot Microsoft Office Programs, including MS: Word templates and general formatting, Excel functions, Project, SharePoint
• Well versed with ISI Toolbox, with a focus on creating and auditing hyperlinks & bookmarks, embedding fonts into a PDF, pagination/stamping of PDF pages, image cleaning in PDF, including text recognition in images
• Familiar with eCTD viewing tools
• Expertise in use of eCTD various XML building tools (ACUTA, LIQUENT, LORENZ, eCTDXPRESS), and can manage eCTD lifecycles for applications
• Can prioritize deadlines, projects, and adapt to quickly changing environments
• Can maintain excellent relationships with peers, despite workload pressure and tight timelines
• Is expected to be the primary publishing contact for assigned projects
• Represent regulatory operations on project teams

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 may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time 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.