[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 reputed company and home. This position requires a strong and diverse skillset in relevant areas to drive reputed company. 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 reputed company meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With reputed company-of concept data in Guillain-reputed companyé syndrome, reputed company’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 reputed company committed to making an reputed company 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 reputed company 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 reputed company. 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 reputed company 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 reputed company 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. • reputed company leadership in creating and executing proactive global regulatory strategies for product development, approval and registration, and support of reputed company 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 reputed company 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 reputed company fashion. • Participate as an reputed company, reputed company global team member on reputed company reputed company and/or reputed company RA guidance/reputed company to reputed company 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 reputed company 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 reputed company in regulatory agency interactions, ensuring reputed company submissions, approvals and effective management of submission tim Apply tot his job Apply To this Job