Executive Director, Regulatory Affairs
Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
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 individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
EXECUTIVE DIRECTOR, REGULATORY AFFAIRS
Ionis Pharmaceuticals is the industry leader in discovery and development of antisense oligonucleotides and is seeking an Executive Director of Regulatory Affairs. This individual will report directly to the Vice President, Regulatory Affairs and will work internally with the matrix teams and with development partners to execute efficient regulatory plans. This individual must be highly skilled and provide expertise in both clinical and nonclinical regulatory strategy. Experience with rare disease/orphan drug development, the FDA Division of Neurology Products and/or the FDA Division of Cardiovascular and Renal Products is a plus.
- Develops the global regulatory strategy for individual programs including preparing the programs for successful registration in all major global markets
- Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
- Provide regulatory perspective and leadership to multiple project teams
- Author and compile FDA and Ex-US regulatory applications and submissions, inclusive of marketing authorization applications, annual reports, etc.
- Lead preparations for, and participate in, meetings with regulatory agencies to ensure efficient drug approvals
- Oversee external vendor to ensure on-time preparation and publication of regulatory submission documents in coordination with the Regulatory Operations function
- Identify relevant and emergent development and commercial guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure guidance is implemented into development planning and execution
- 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
- Ensure regulatory documentation is maintained appropriately
- Manage and mentor Regulatory Affairs team members
- Other duties as assigned
- Bachelor’s Degree required; advanced degree preferred
- At least 15 years of increasing Regulatory Affairs experience and responsibility
- Solid working knowledge of relevant domestic and global regulations and guidance
- Exercise outstanding judgment in all areas of responsibility
- History of successful interactions with global regulatory authorities
- 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
- Strong interest in mentoring and training more junior Regulatory Affairs team members
- Productive and successful in an intense work environment
- Willing to travel domestically and internationally up to 15%
Excellent salary and benefits package offered.
Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition # 18-0107
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.