Manager, Regulatory Operations
MANAGER, REGULATORY OPERATIONS – Remote Position
As the Manager, Regulatory Operations , you will be responsible for processes and/or serve as a primary contact for key external relationships within a department. Provide guidance and/or establish framework and create and execute project plans. This will be an individual contributor role and report to an Associate Director, Regulatory Affairs.
Come join us and be part of an exciting and highly collaborative team in this unique time of growth and opportunities at GBT!
Essential Duties and Responsibilities:
- 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
- A minimum of 5-8+ years of relevant experience and has earned a BS or equivalent degree. Experience providing guidance to less experienced team members.
- eSubmission working experience with eCTD tools, the FDA and EMA (ex-US publishing experience would be a plus)
- 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
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.
Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.