Commercial Regulatory Associate Director or Director

This Bay Area pharmaceutical company is developing and commercializing innovative therapies for women’s health and prostate cancer.  With the anticipated FDA approval of two NDAs this year, they are seeking an Associate Director or Director of Commercial Regulatory Affairs who can review and approve promotional materials for upcoming product launches. This role involves interacting with commercial, medical, legal, and OPDP on a regular basis.   This role can be remote with some occasional travel.  This company offers an incredible company culture, competitive compensation, equity, and great employee benefits.  Now is an exciting time to join this rapidly growing organization and bring new products to market!

Key Responsibilities

  • Review US promotional materials, disease awareness communications, field medical materials, sales training materials, and corporate communications.
  • Attend the Medical/Legal/Regulatory review committee and provide regulatory guidance to the cross-functional team responsible for ensuring material compliance with company policies and FDA regulations.
  • Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and company policies.
  • In collaboration with the VP of Commercial Regulatory, serve as the contact for communications with the OPDP for assigned products.
  • Ensure timely submission of all applicable approved promotional materials to the FDA on Form 2253s.
  • Review and revise regulatory policies to ensure compliance with FDA requirements.
  • Provide internal training support on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences.
  • Provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products within the company pipeline.
  • Ensures stakeholder awareness of proposed and newly approved labeling changes and FDA guidance documents.
  • Provide guidance to Medical/Legal/Regulatory review committee to ensure appropriate implementation for assigned product, including updating and managing versions of the HCP and Consumer ISI for promotional materials in a timely manner.
  • Participate in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials.
  • Help develop best practices for the commercial regulatory department to establish standards and consistency across company products
  • Participate in professional associations and training meetings related to advertising and promotion regulatory requirements and relevant medical congresses within assigned therapeutic areas.

 Qualifications

  • Bachelors degree in a scientific discipline required. Advanced degree (MS, PhD, PharmD) preferred.
  • At least five years in pharmaceutical or biotech industry with at least three years in regulatory affairs advertising and promotion.
  • Solid knowledge of U.S. FDA advertising and promotional regulations.
  • Direct experience communicating and negotiating with OPDP.
  • Direct experience leading a recent product launch preferred.
  • Digital review experience desired.
  • Experience with FDA standards for advertising and promotion compliance.
  • Strong listening, verbal, and written communication and presentation skills.
  • Knowledgeable on industry compliance requirements and enforcement trends.
  • Strong interpersonal skills.
  • Proven ability to prioritize and to manage multiple competing tasks and demands and meet critical business timelines.

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