Regulatory Advertising & Promotions Senior Director

This company is developing and commercializing novel therapeutics for the treatment of nonalcoholic steatohepatitis (NASH). They are seeking a Regulatory Advertising & Promotions Senior Director to provide commercial regulatory strategy and direction to the organization. Reporting into the SVP of Regulatory, you will be responsible for promotional review for their lead candidate and other programs. This company offers a collaborative, patient-focused culture and hybrid working arrangements.  With one approved product and a strong cash position, now is an exciting time to join this rapidly growing organization.

Responsibilities:

  • Review of promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
  • Represent the commercial regulatory perspective at and chair the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Legal/Compliance.
  • Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP).
  • Manage interaction with OPDP including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP staff.
  • Lead and manage all necessary regulatory operational needs such as enhancements to internal systems, subpart H pre-clearance submissions, and Form 2253 submissions.
  • Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts.
  • Provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.
  • Serve as internal expert on FDA regulations governing the promotion of company’s products.
  • Participate in company working groups on advertising and promotion standards and guidelines.

 

Knowledge and Skills:

  • Bachelors degree required. Advanced degree (MS, PhD, or PharmD) preferred.
  • 10+ years of Pharmaceutical/Biotech industry experience with eight or more years in Regulatory Advertising & Promotions.
  • Experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents, including significant Subpart H and/or Subpart E experience.
  • Must have prior product launch experience.
  • Ability to navigate complex regulatory framework while remaining solutions-oriented to address corporate objectives.
  • Must have direct experience negotiating with FDA’s Office of Prescription Drug Promotion (OPDP).
  • Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
  • Ability to assume a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities.
  • Strong interpersonal skills, including conflict management and negotiation skills.
  • Outstanding interpersonal and communication (written and verbal) skills.
  • Willing to roll up sleeves and do whatever is needed to ensure Regulatory success.
  • Must be comfortable with ambiguity in a small company environment

This company has offices in the Greater Philadelphia area and in the Boston area. The Senior Director must be onsite three days a week in one of these locations.

The budgeted salary range for this position is US$250,000 to $290,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

Apply for this Position

    Your Name*

    Your Email*

    Resume

    Your Message

    This entry was posted in . Bookmark the permalink.