Director of Regulatory Affairs, Advertising and Promotion

10 Jul, 2022

Jobs

Director of Regulatory Affairs, Advertising and Promotion

Ardelyx
Fremont, CA

Description

Ardelyx is a publicly-traded biopharmaceutical company founded with a mission to discover, develop, and commercialize innovative first-in-class medicines that address significant unmet medical needs and advance patient care.  Ardelyx plans to launch the company’s first-in-class, novel mechanism therapy, approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults, in the second quarter of 2022. Ardelyx is also pursuing approval of tenapanor, an investigational first-in-class phosphate absorption inhibitor that has completed three successful phase 3 trials.

Director of Regulatory Affairs, Advertising and Promotion

Purpose of the role:

 

The Director of Regulatory Affairs, Advertising and Promotion will be responsible for providing strategic guidance on the advertising and promotion activities for the company’s commercial products. This role will work with limited supervision to review and provide strategic advice on advertising & promotion materials, in accordance with the requirements of the US Food and Drug Administration (FDA), company policy, and business goals and objectives. The Director will also ensure effective communication and constructive working relationships with regulatory authorities and internal/external collaborators. Responsibilities may also include supporting or leading other projects related to pre-or post-marketing aspects of regulatory affairs (e.g, medical affairs materials, labeling, post-marketing commitments/requirements, annual reports, etc.).

Position Responsibilities:
 

  • Provides strategic regulatory guidance on promotional materials and activities for commercial products in accordance with FDA regulations/guidance, PhRMA guidelines, and business objectives. Serves as the primary regulatory reviewer on the Promotional Review Committee (PRC). Acts as primary contact with FDA’s Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review.
  • Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.
  • Prepares submissions to OPDP for advisory review (e.g., core launch materials, DTC advertisements, general advice, etc.) and complaint letters, in collaboration with PRC if needed.
  • Works closely with Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.
  • Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
  • Provides regulatory input to teams on draft product labeling and study designs/development plans with regards to the feasibility of promoting potential claims; may also lead competitive label assessments, key claims assessments, and generation of draft labeling for products in development.
  • May support the filing of NDAs and supplements.

 

Core Competencies, Knowledge and Skill Requirements:

 

  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) Communication & Interpersonal Skills
  • Excellent verbal and written communication skills
  • Ability to effectively collaborate in a dynamic environment

 

 Position Requirements:

  • BA/BS Degree. Advanced degree desirable (MS, Pharm.D., Ph.D). Experience:
  • 8+ years of pharmaceutical industry experience, with at least 6 years of experience focused on the regulatory review of advertising and promotion materials for prescription drug products.
  • A strong understanding of US regulatory regulations/guidance for advertising/promotion and labeling are a must.
  • Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate
  • Solid understanding of business goals and common marketing concepts/tools, including the internet and social media
  • Experience with ex-US promotional activities a plus
  • Knowledge of NDA/sNDA filings a plus
  • 15% Travel to attend Health Authority meetings, domestic training seminars and possibly meet with corporate partners

Ardelyx currently maintains a policy requiring all employees to be fully vaccinated against COVID-19 in accordance with CDC guidelines.  Newly hired employees must be fully vaccinated prior to their employment start date.  Ardelyx is an equal opportunity employer and will provide reasonable accommodations for those unable to be vaccinated who qualify for exemption in accordance with applicable law.

Job posted: 2022-07-10