Director or Executive Director of Regulatory Affairs

Isis Pharmaceuticals   •  

Carlsbad, CA

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 53 days ago

Description

Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 and was purposely designed to create a better, more efficient drug discovery platform, establish a new innovation-centered business model, and maximize the value of every medicine created and get it to the people who need it most as quickly and as efficiently as possible.

With the RNA molecule as the basis of our novel drug discovery platform, we are targeting an unprecedented range of therapeutic areas. Our antisense therapies are disrupting diseases and changing their course—from the rarest of conditions, to those that impact millions of people. We currently have three commercial products and more than 40 potentially transformative medicines in our pipeline designed to treat a broad range of diseases.

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 OR EXECUTIVE DIRECTOR OF REGULATORY AFFAIRS

The Director or Executive Director, Regulatory Affairs will help develop regulatory strategy and be an active partner in drug development project planning and execution. This is an individual contributor role, reporting directly to the Vice President, Regulatory Affairs. This position will work within cross-company development project teams and will provide expertise in translating clinical and nonclinical 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 global regulatory agency interactions. Experience with rare disease/orphan drug development and/or cardiometabolic or renal targeted therapeutics is a plus. This position will be the responsible RA lead for multiple compounds in development.

RESPONSIBILITIES:

  • 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.
  • Lead preparations for, and participate in, meetings with regulatory agencies to ensure efficient drug approvals
  • 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
  • Manage and mentor Regulatory Affairs team members
  • Other duties as assigned

REQUIREMENTS:

  • Bachelor's Degree required; advanced degree preferred
  • At least 10 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
  • 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 15%