Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.

As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and 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 group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.

ASSOCIATE DIRECTOR, GLOBAL REGULATORY AFFAIRS

The Associate Director, Global Regulatory Affairs will help develop Global regulatory strategy and be an active partner in drug development project planning and execution. This is an individual contributor role, reporting to the Executive Director, Regulatory Affairs. This position will work within cross functional development project teams and will provide expertise in translating commercial, clinical and nonclinical regulatory requirements into practical strategic regulatory plans. This individual will implement these plans through coordination, authorship and development of domestic and international drug applications and submissions, and through regulatory agency interactions.

RESPONSIBILITIES

• In conjunction with RA department leadership, ensure optimal acceptable regulatory strategies for worldwide compliance and submissions, in an environment committed to the efficient development of new drugs for patients
• Author and compile FDA and Ex-US regulatory applications and submissions, inclusive of general correspondence, INDs, CTAs, protocol and information amendments, annual reports, meeting briefing documents and NDAs
• Lead preparations for, and participate in, meetings with regulatory agencies to ensure efficient drug development and drug approvals
• Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents
• Identify relevant and emergent guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure they are implemented into development planning and execution
• Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
• Prepare information or responses as requested by regulatory agencies
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
• Review clinical protocols to ensure collection of data needed for regulatory submissions
• Review safety reports and file all required reports in accordance with regulatory agency guidelines, including safety surveillance reports and other post-approval documents
• Ensure regulatory documentation is maintained appropriately
• Other duties as assigned

REQUIREMENTS

• Bachelor’s Degree required; advanced degree preferred
• At least 8 years of increasing Regulatory Affairs experience and responsibility
• Solid working knowledge of relevant domestic and global regulations and guidance
• History of successful interactions with global regulatory authorities
• Energetic, self-motivated and a hands-on professional with a strong work ethic
• Ability to perform independently and think analytically and creatively to solve problems
• Effectively lead and manage multiple time-sensitive projects
• Ability to be a true team player working toward common goals
• Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally
• An ability to be productive and successful in an intense work environment

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition #IONIS003117

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is$142,046 to $188,220

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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