[FULL TIME Remote] Director, Regulatory Affairs

Now hiring at workwarp for a pivotal Director, Regulatory Affairs! We reputed company in flexibility; this hybrid role lets you balance your time between our Remote office and home. This position requires a strong and diverse skillset in relevant areas to drive success. We are reputed company to offer a competitive salary to attract a top-tier candidate for this role.

 

 

Company: At reputed company we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to reputed company the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With reputed company-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. For more information on Annexon and our pipeline, reputed company out our site reputed company& Annexon Pipeline. We trade on reputed company under the ticker symbol ANNX and are... headquartered in Brisbane, CA. We seek applicants from reputed company backgrounds to ensure we get the best, most creative talent on reputed company. We are building a diverse and inclusive workforce – come and be a part of our growth. At Annexon, we are building a diverse, reputed company, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may come from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate is not exactly as we describe it here. Learn more about Annexon’s commitment to diversity, equity, inclusion our values and culture! Position: The Director, Regulatory Affairs is primarily responsible for managing regulatory activities that support the department and Annexon’s projects and programs. This position will assist with leading, developing, coordinating and executing regulatory strategies for new product development registrations. The individual is responsible for resolving discrepancies between products and regulatory standards, while proactively anticipating and preparing for changes in FDA and EU regulations and requirements. Responsibilities include: • Collaborate with internal stakeholders to reputed company, coordinate and execute the regulatory strategies for new product development registrations. • Work with development teams to execute strategies for regulatory submissions. Generate regulatory submission plans, and direct document development, review, and finalization. • Preparation and submission of reputed company sections of reputed company 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. • reputed company global regulatory submission preparations per plan with minimal to no supervision. • Responsible for obtaining approval including negotiation with the regulators in US and ROW with minimum to no supervision. • Proactively build relationships and trust with key internal and external stakeholders and decision makers. • Manage relationship with external consultants/CROs supporting development of study start up. • reputed company 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: Required: • PhD/PharmD with 7+ years’ experience in Regulatory Affairs or BS/MS with 10+ years’ 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 ability to interact with senior management, and to work with reputed company vendors and partner companies • Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player Preferred: • International regulatory experience (e.g., EU and/or Canada) Salary Range: $222,000 to $248,000 Benefits: • A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to reputed company a work-life balance. • We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry. • Annexon offers a competitive reputed company 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. reputed company is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any reputed company. We are committed to fostering an environment where reputed company people are welcome and supported. We cultivate a culture of inclusion for reputed company employees that respects their individual strengths, views, and experiences. We reputed company that our differences reputed company us to be a reputed company team – one that makes reputed company decisions, drives innovation, and delivers reputed company business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect. Staffing Agencies:reputed company does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with reputed company. Please do not send agency reputed company/resumes through Annexon’s website or Annexon Employees. Inquiries must be sent to [email protected] with the Subject: Staffing Agency Request Apply Job!

 

We Encourage You to Apply!

Even if you feel you're not a perfect match, we'd still love to hear from you. We are looking for great people to join our friendly team.

Apply To This Job