Director of Global 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.
DIRECTOR OF GLOBAL REGULATORY AFFAIRS
This individual will be a key driver of developing regulatory strategy and an active partner in drug project planning and execution for inotersen to treat hATTR, a devastating, progressive and fatal disease. Inotersen is currently under regulatory review for marketing authorization in the US and EU.
This is an individual contributor role, reporting directly to the Ionis Vice President, Regulatory Affairs. This individual will work within cross-company project teams and will provide expertise in translating clinical, nonclinical and CMC 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.
- Ensure optimal acceptable regulatory strategies for worldwide compliance and submissions through commercial launch
- 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, supplements and variations, annual reports, general correspondence, etc.
- Provide regulatory oversight of advertising and promotional activities
- Prepare labeling documents for international regulatory submissions in compliance with applicable regulations and policies
- Contribute to efficient labeling processes for core and regional labeling
- 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 commercial guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure guidance is 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
- Ensure regulatory documentation is maintained appropriately
- Other duties as assigned
- Bachelor’s Degree required; advanced degree preferred
- At least 10 years of increasing Regulatory Affairs experience and responsibility
- Strong commercial drug marketing experience is a must
- 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
- Ability to be a true team player working for the common goal of the successful launch and commercialization of Inotersen
- Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally
- Productive and successful in an intense work environment
- Willing to travel domestically and internationally up to 20%
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 #17-0191
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.