Director of Regulatory Operations
Company: Scientific Search
Location: Redwood City
Posted on: January 6, 2022
Director, Regulatory Operations
Location-Near San Francisco, CA
Check out www.scientificsearch.com for all of our openings
The Director of Regulatory Operations will be responsible for
working hands on and managing a small Regulatory Operations team to
complete the Regulatory Operations activities. In this fast-paced
environment, he/she will have the opportunity to work in a hands-on
capacity to work on projects from new product concepts through
marketed products. He/she will be a creative and independent
thinker while supporting and facilitating a solid team effort in
meeting company goals.
Principal Responsibilities And Duties
The Regulatory Operations Associate Director/Director and
Regulatory Operations team is responsible for:
- Working closely with Regulatory Affairs, Program Management,
and Product Development Teams to provide operational oversight and
support for the planning, preparation, tracking, and timely
submission of all eCTD applications and updates to global health
authorities (e.g. IND, NDA, BLA, MAA, etc.).
- Managing all publishing activities including: ensuring
documents are submission ready, preparation and transfer of final
documents to a third-party publishing organization, troubleshooting
and supporting the third-party publisher during submission
preparation, managing and completing QC of output from third-party
publisher, confirming submission to the health authority.
- Managing all communications, planning, and other activities
with a third-party publishing organization.
- Tracking regulatory commitments and deliverables to health
- Managing all activities and communications with third-party
- Providing input and guidance on current technical aspects of
submission requirements such as CDISC nonclinical and clinical
dataset requirements, etc.
- Leading the development and implementation of standard
procedures for publishing, archiving, metrics, and submission
process to global health authorities.
- Developing and maintaining templates and style guides for
- Maintaining an index and archive of all regulatory submissions
- Maintaining and improving our sharepoint site used for
authoring of regulatory documents.
- Manages the evaluation and implementation of a regulatory
- Monitors and assesses business trends, pending regulations or
guidance documents and emerging technologies for potential
regulatory operations impact, develop action plans, countries
requirements guides, and business tools accordingly.
- Supports budgeting and forecasting activities, including
managing expenditures activities related to approved vendor
Education/Experience/Skills: The ideal candidate will offer:
- A BS, or advanced degree, in life/physical sciences with 7+
years regulatory affairs or regulatory operations experience within
the pharmaceutical or biotechnology industry.
- Regulatory submissions experience particularly with large
applications such as NDA, BLA, MAA etc. Ideally experienced in all
phases of product development, pre- and post-marketing.
- Experience managing a team.
- Experience implementing and maintaining document management
- A strategic as well as an operational approach with the ability
to "think outside the box" and to manage multiple tasks in a
- Excellent problem-solving ability and organizational skills,
while maintaining attention to detail. A high energy level, a
willingness and ability to work in a hands-on capacity, to adapt
and respond to a rapidly changing environment, and to work
effectively in a project team environment.
- Effective verbal and written communication skills, excellent
interpersonal skills, and a team approach.
- The ability to establish and maintain excellent relationships
when dealing with sensitive and/or complex issues and tight
For immediate consideration, email firstname.lastname@example.org
Keywords: Scientific Search, Redwood City , Director of Regulatory Operations, Executive , Redwood City, California
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