Director, Regulatory Operations

Work Location

Position Summary

Responsibilities

• Be the first Regulatory Operations hire for Annexon
• Working closely with Regulatory Affairs, Program Management, Product Development, Medical Writing, and partners to provide operational oversight and support for the planning, preparation, tracking, and timely submission of all eCTD and non-eCTD Submissions to global health authorities (e.g. IND, NDA, BLA, MAA, etc.).
• Manage all technical aspects for submissions such as advising authors of required eCTD document granularity, utilization of content templates, style guide, document formatting, eCTD application location, publishing, QC, validation, and transmission to regulatory health authorities.
• Assist the cross-functional team in inspection readiness preparation
• Manage effective and up-to-date Archiving systems; maintain initial applications and amendments across global development programs
• Identify, analyze, and implement applicable industry technologies in accordance with applicable regulations, for sustainability and scalability of the organization and propose changes accordingly. Identify issues that will impact programs and provide proactive strategies for dealing with them. 
• Maintain knowledge of current global regulatory requirements for submission formats.
• Work with Regulatory Affairs and contributing functional areas in establishing submission plans. Oversee and/or prepare Regulatory submissions globally using internal and external resources.
• Participate in the interpretation and implementation of new health agency guidelines and rules relevant to regulatory submissions
• Works on all aspects of planning, creating, publishing, submitting, and archiving of regulatory submissions to Health Authorities. Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
• Leads the training of appropriate R&D staff in the application of various standards and technologies including templates, document management practices, eCTD publishing, and other tools used within the group.
• As assigned, oversees RA compliance and quality activities (training, onboarding, quality metrics for submissions, CAPA management, support of inspections) as key partner for Quality Assurance
• As a global submissions’ expert, ensure the project team has awareness and knowledge of e submissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.
• Other duties as required.

Qualifications

• BS or BA in science / technology or an equivalent combination of education and experience preferred.
• A minimum of at least 10 years of proven experience in a Regulatory Operations role within the pharmaceutical or biotech industry.
• Current and strong working knowledge of electronic document and submission standards and requirements (CTD/eCTD structure) applicable to the US, EU and global regulatory environments.
• Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools
• Knowledge of IT systems and electronic submission requirements and processes
• Knowledge of CDISC (ADaM, SEND, SDTM).
• Excellent understanding of structure of reports and submission documents.
• Experienced in managing web-based content and document management environments (e.g. SharePoint, Veeva, EDMS solutions).
• Must have a strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
• Must be able to assist management in prioritizing and balancing multiple tasks to accomplish department goals.
• Works under minimal supervision and independently determines and develops solutions to moderately complex problems.
• This position requires the ability to master new technical skills and apply them to projects as the industry and the company evolves.
• Shows strong initiative and drive. Must be an organized self-starter who is able to anticipate departmental needs.
• Excellent organizational, communication, attention to detail, and time management skills.
• Excellent interpersonal skills and ability to work successfully within a cross-functional team.
• Possesses a thorough knowledge of current FDA regulations and guidance of requirements for investigational products, IND/NDA submission requirements, and CMC information.  Must be able to generate regulatory strategies and provide leadership to multidisciplinary teams. 
• S/he should have a track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical products.
• Possesses leadership skills and ability to interact with outside vendors and partner companies.
• Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player.

What Annexon offers

• Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. To learn more about our diversity commitment, culture and values, visit https://annexonbio.com/careers/
• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.

Company Summary

EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging