About Annexon Biosciences
At Annexon Biosciences, we are a pioneering biopharmaceutical company dedicated to advancing novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our groundbreaking scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and our therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative, and ophthalmic diseases. With proof-of-concept data in Guillain-Barré syndrome, Huntington’s disease, and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.
Job Summary
We are seeking an experienced Director, Regulatory Affairs to join our team. This pivotal role will be responsible for managing regulatory activities that support the department and Annexon’s projects and programs. The ideal candidate will have a strong and diverse skillset in relevant areas to drive success, with a proven track record of leading, developing, coordinating, and executing regulatory strategies for new product development registrations.
Responsibilities
- Collaborate with internal stakeholders to develop, coordinate, and execute the regulatory strategies for new product development registrations.
- Work with development teams to execute strategies for regulatory submissions, generating regulatory submission plans, and directing document development, review, and finalization.
- Preparation and submission of all sections of all filings to regulatory authorities, including, but not limited to, IND, NDA, CTA, and MAA applications.
- Provide leadership in creating and executing proactive global regulatory strategies for product development, approval, and registration, and support of future programs.
- Lead global regulatory submission preparations per plan with minimal to no supervision.
- Responsible for obtaining approval, including negotiation with regulators in the US and ROW, with minimal to no supervision.
- Proactively build relationships and trust with key internal and external stakeholders and decision-makers.
- Manage relationships with external consultants/CROs supporting development of study start-up.
- Develop and implement regulatory strategies, including regulatory risk management, ensuring that any RA issues are highlighted and addressed satisfactorily and in a timely fashion.
- Participate as an active, engaged global team member on core projects and/or provide RA guidance/strategy to core team members.
- Other tasks as needed to support the Regulatory group.
Education, Experience, and Skills
We are looking for a highly qualified candidate with the following requirements:
- PhD/PharmD with 7+ years of experience in Regulatory Affairs or BS/MS with 10+ years of experience.
- Has primary responsibility for coordinating the preparation of drafts, edits, review, and submission of regulatory dossiers in support of investigational and new drug applications.
- Superior scientific writing skills for developing regulatory documents.
- Possesses in-depth knowledge of FDA regulations, including CTD/eCTD, and requirements for investigational products, IND, and BLA submissions, with direct experience working with FDA.
- Supports the department in generating regulatory strategies, providing leadership to multidisciplinary teams, while working with project teams and management to identify regulatory risks and ensure the earliest possible arrival.
- Proven success in regulatory agency interactions, ensuring timely submissions, approvals, and effective management of submission timelines.
- Possesses leadership skills and the ability to interact with senior management, and to work 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.
Preferred qualifications include international regulatory experience (e.g., EU and/or Canada).
Career Growth Opportunities and Learning Benefits
At Annexon Biosciences, we are committed to fostering an environment that supports the growth and development of our employees. As a Director, Regulatory Affairs, you will have opportunities to:
- Develop and implement regulatory strategies that support the company's projects and programs.
- Collaborate with internal stakeholders to drive success and achieve regulatory goals.
- Participate in training and development programs to enhance your skills and knowledge.
- Contribute to the development of the Regulatory Affairs team and the company's overall success.
Work Environment and Company Culture
At Annexon Biosciences, we value diversity, equity, inclusion, and innovation. We are committed to fostering an environment that is welcoming, inclusive, and respectful of all employees. Our company culture is built on the principles of:
- Diversity and inclusion: We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results.
- Equity: We are committed to fostering an environment where all employees feel valued, respected, and supported.
- Innovation: We encourage creativity, experimentation, and risk-taking to drive innovation and growth.
- Respect: We value respect for all employees, customers, and partners.
Compensation, Perks, and Benefits
We offer 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, and other benefits. Additionally, we offer:
- A stimulating and rewarding workplace that includes flexible work schedules, remote opportunities, and the ability to achieve a work-life balance.
- A shuttle service from BART, CalTrain, and the Ferry.
- Opportunities for professional growth and development.
How to Apply
If you are a motivated and experienced professional looking for a challenging and rewarding opportunity, please submit your application through our website. We encourage you to apply, even if you feel you're not a perfect match. We are looking for great people to join our friendly team.
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