Executive Director/ Senior Director, Regulatory Affairs

2 days ago

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Annexon Biosciences

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Unlocking the Next Generation of Complement Therapies

Neurodegeneration • Autoimmune • Ophthalmology

51 - 200

💰 $130M Post-IPO Equity on 2022-07

Description

• This role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs within the Annexon portfolio. • Responsibilities include developing regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with regulatory agencies to support development and registration strategies. • The Executive Director/Senior Director, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs. • Additionally, this individual will mentor junior members of the regulatory team and anticipate and plan for changes in FDA and EU regulations and requirements.

Requirements

• PhD/PharmD with 12+ years’ experience in Regulatory Affairs or BS/MS/MSN with 14+ years’ experience. • Experience in a successful leadership role in managing, developing late-stage clinical candidate drugs. • Experience in working directly with the FDA and EMA. In-depth knowledge of FDA regulations, EMA regulations, and knowledge of CTD/eCTD. • Superior scientific writing skills for developing regulatory documents. • Understands the regulatory environment for pharmaceutical companies, as well as pharmaceutical industry regulatory affairs best practices to satisfy regulatory requirements. • Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends. Ability to engage regulators on new approaches and implement new strategies for product regulatory filings. • Experience with small and large molecules and rare diseases. Experience with division of ophthalmology is a plus. • Develops and maintains strong collaborative internal and external working relationships. • 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.