Director, Regulatory Operations

2 days ago

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Annexon Biosciences

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Unlocking the Next Generation of Complement Therapies

Neurodegeneration • Autoimmune • Ophthalmology

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💰 $130M Post-IPO Equity on 2022-07

Description

• Oversee regulatory publishing efforts of multiple programs. • Manage outsourced regulatory publishing activities. • Ensure timely delivery of submission packages. • Drive improvement and efficiency in Regulatory archives. • Lead systems projects and oversee RA compliance activities. • Participate in developing Regulatory Operations processes.

Requirements

• 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.

Benefits

• Diversity, Equity, Inclusion, and Belonging are important to us. • 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.