Director, Regulatory Affairs

For more than 30 years, Ionis Pharmaceuticals has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Scientific innovation began and continues at Ionis with the understanding that sick people depend on us.

As the first company to fully harness the power of RNA technology for human therapeutics, our platform continues to revolutionize drug discovery and transform the lives of patients with unmet needs. Our medicines span multiple therapeutic areas, routes of administration and diverse patient populations. Ionis innovation is driving meaningful progress for many of the most challenging health issues.

We are building upon our innovative research and drug development excellence to provide greater value to patients. Based on the breadth and remarkable progress of our pipeline, Ionis is projecting to have a vast number of new transformational products on the market in the coming years and growing our commercial capabilities. We are well positioned financially to deliver on our strategic goals.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse workforce, comprised of individuals from different backgrounds and with unique skill sets, into our creative and productive environment. Join us and experience our unique culture while you develop and expand your career.

DIRECTOR OF REGULATORY AFFAIRS

SUMMARY:

A Director of Regulatory Affairs is sought to join the team developing eplontersen, an investigational medicine designed to reduce the production of transthyretin and in phase 3 development for the treatment ATTR-polyneuropathy and ATTR-cardiomyopathy. Eplontersen is partnered with AstraZeneca and is at an exciting stage of development. This position will work within cross-company project teams on strategic planning and execution of all aspects of regulatory affairs. A successful candidate will have experience with preparation and submission of New Drug Applications, late-stage drug development to launch, and US and international regulatory interactions.

RESPONSIBILITIES:

• Lead and execute on regulatory strategies for assigned programs and their lifecycle management
• Represent Regulatory in cross-functional and cross-company teams and provide strategic guidance to teams on the regulatory requirements, precedent, and risk to support clinical development programs
• Lead and support interdepartmental teams in the authoring of high-quality regulatory communications such as regulatory meeting requests, briefing packages, responses to regulatory health authority requests, and NDA/MAA components.
• Lead preparations for, and participate in, meetings with regulatory agencies to ensure efficient drug development, product license approvals and their maintenance
• Plans, prepares and reviews submissions to regulatory authorities including FDA, Health Canada, EMA and other global health authorities to support the conduct of clinical trials and approval of marketing applications (including but not limited to Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA), and Marketing Authorization Application (MAA).
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
• Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development and commercialized programs
• Ensure regulatory documentation is maintained appropriately

• Prepares and revises internal procedures for continuous improvement
• Other duties as assigned

QUALIFICATIONS:

• Bachelor’s Degree in a scientific discipline required; advanced degree preferred
• Minimum of 10 years of experience working in the pharmaceutical/biotechnology industry with direct experience in Regulatory Affairs and demonstrated ability to present and articulate requirements and influence teams

• Experience in Phases 1-3 and commercial product lifecycle
• Experience in preparation and submissions of INDs/CTAs and NDAs/MAAs
• Familiarity with the interpretation of applicable FDA, Canadian, EU, and ICH guidelines related to clinical trial and marketing applications

• Exercise outstanding judgment in all areas of responsibility
• History of successful interactions with regulatory authorities
• Proven ability to effectively work collaboratively in cross-functional teams and lead team discussions
• Energetic, self-motivated and a hands-on professional with a strong work ethic
• Capable of performing independently and thinking analytically and creatively to solve problems
• Effectively lead and manage multiple time-sensitive projects
• Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally
• Willing to travel domestically and internationally up to 15%

Excellent salary and benefits package offered.
For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition #IONIS002923

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.