Senior Director Regulatory Operations

Arcus Biosciences•Hayward, CA

7d•$265,000 - $295,000•Remote

About The Position

The Senior Director of Regulatory Operations (RO) will be responsible for independently managing multiple operational components of regulatory submission production, maintenance processes, and/or Information Management in support of Arcus’s product portfolio. This position will also independently develop, implement, maintain and manage the submission strategy for areas of responsibility in alignment with the global Regulatory strategy. This position is responsible for coordinating operational aspects of implementing Regulatory strategy and business that will contribute to helping Regulatory Affairs and ensuring global Regulatory Compliance. These groups include Regulatory Submission Publishing, Archiving, Regulatory Systems, Regulatory Project Management, Regulatory Information Management, and may include oversight on EU CTIS submission, Data Disclosure, and Regulatory Intelligence. This position is responsible for ensuring that the core competencies of regulatory affairs are maximized and delivered on in the most efficient way possible. This includes managing electronic and paper publishing of submission documents, filing processes for global regulatory submissions and establishment of compliant electronic submission and archival processes for submissions; managing the interface with Information Technology for the selection, implementation and maintenance of technology platforms for Regulatory Affairs to enable the global submission process and all related Regulatory Affairs function; and ensuring that the Regulatory department is proactively managing guidance and regulation changes, developing and documenting processes, ensuring registration tracking and management is meeting corporate and health authority requirements. Arcus is seeking candidates with a can-do attitude who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven decision making. This newly created position reports directly to the VP of Regulatory Affairs.

Requirements

Bachelor’s degree in Life Science or other related discipline with 12 years regulatory experience or Master’s degree in Life Science or other related discipline and 10 years regulatory experience.
Minimum of 6 years’ experience in a regulatory operations leadership role.
Leadership skills in managing people.
A strong team player.
Strong written and verbal communication skills.
Ability to work independently with moderate supervision on multiple projects simultaneously.
Detail oriented with creative problem solving and troubleshooting skills.
Working knowledge of applicable U.S. and international regulations and guidelines.
Experience with electronic submissions (eCTD) and publishing tools, ISI Toolbox, and templates.
Experience with Veeva Vault for Submissions and/or other similar Document Management Systems.
Exceptional interpersonal skills with the ability to work individually and within multi-disciplinary teams.
Excellent oral and written communication skills and superior project planning skills.
The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, innovative environment.

Responsibilities

Leadership role in the development of compliant GXP electronic systems and paper methods; plans, prepares, and tracks regulatory electronic documents and submissions ensuring conformance with regulatory requirements, guidelines, internal standards and timelines.
Monitors and assesses business trends, pending relevant regulations or guidance documents and emerging technologies for potential regulatory operations impact, develop action plans and business tools accordingly.
Supports budgeting and forecasting activities, including managing expenditures activities related to approved vendor contracts for outsourcing of regulatory submissions.
Assist with resourcing and contracting for vendors that provide external Regulatory Operations tasks, oversee and coordinate vendors, and ensure project delivery.
Interact with and serve as resource for Regulatory Operations team to plan support of compliance activities and inspection readiness.
Work across company disciplines to ensure timely delivery of submission documents.
Manage worldwide regulatory electronic and paper submissions and regulatory operations team ensuring submission timelines and submission quality standards are met.
Collaborate with submission stakeholders to plan major submissions and the global roll-out of submissions. Based on these outputs prepare a submission forecast to ensure that the Regulatory team is adequately resourced.
May oversee the general and overall coordination of Disclosure, Transparency and Data sharing of information to regulatory authorities and the public of information provided in Regulatory Submissions.
Partner with departments outside of Regulatory, who are responsible for the content for a submission, to ensure quality Regulatory submissions are made on time.
Organize and manage meetings with departments outside of Regulatory to coordinate, plan, and track submissions for Regulatory.
Manage the Arcus formatting style guide and glossary to assist formatters in generating consistent, high quality formatted documents for submission (eg, StartingPoint).
Leads the process of identifying submission preparation software, definition of user requirements, implementation of software systems, validation, and seamless establishment of these systems to support global Regulatory Affairs.
Responsible for the business administration of these platforms per software lifecycle management, including updates and upgrades.
Ensures proactive management and engagement with regulatory agencies around new guidance and regulations, performing impact analysis on the company and ensuring that the Regulatory group is prepared to meet the requirements.
Assist with development of SOPs as necessary to ensure consistency and high standards in Regulatory Operations and coordination with other teams.
Working Knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to: amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc.
Assist in the maintenance of document standards, templates, and procedures related to the formatting, publishing and archiving of both electronic and paper submissions according to company regulatory standards.
Work with project teams to maximize the use and value of document templates.
Develop KPIs and other analytics to drive Arcus Regulatory Strategy forward.