Director Regulatory Affairs Advertising and Promot
Job Opportunity at Clinical Dynamix, Inc.

Posted on Mar 21

http://www.clinicaldynamix.com    888-558-2546

Job Type: Full Time
Job ID: W4153223

Director/Sr Dir Regulatory Affairs Advertising & Promotions

Cambridge, MA , or Boulder, CO

This individual will report to the Vice President of Regulatory Affairs (Strategy & Execution Group).
The Dir./Sr. Dir. Advertising & Promotions is accountable for the entire process and review of all advertising and promotions material to support commercial products.  Including:
  • Provide regulatory oversight of all advertising and promotional activities for commercial products
  • Develop an optimized process to support the multidisciplinary review of promotional material
  • Chair the Medical, Legal and Regulatory (MLR) review team; lead strategic discussion and interactions with contributing disciplines
  • Work closely with Regulatory Advertising & Promotions Manager (who manages the MLR process)
  • Provide regulatory subject matter expertise, advice and feedback to key stakeholders (commercial teams, MLR team members, and stakeholder management); identify areas of risk and propose risk-mitigation strategies
  • Liaise with cross-functional teams to ensure scientific and medical communications are non-promotional and compliant with applicable regulations, guidelines, and policies
  • Ensure regulatory compliance while effectively managing business objectives
  • Monitor US regulatory promotional environment by reviewing regulatory promotional guidelines and precedence (e.g., Office of Prescription Drug Promotion OPDP warning letters to pharmaceutical companies)
  • Maintain awareness of competitive activities by attending relevant conferences/meetings where pertinent oncology products are promoted (e.g., ASCO)
  • Oversee and manage interactions with OPDP; establish new and positive working relationship with OPDP reviewers
  • Oversee the compilation and submission of material to regulatory authorities (e.g., OPDP), while ensuring regulatory compliance, timeline commitments, and business objectives
  • Contribute to other post-marketing regulatory activities (i.e., supplemental NDAs), as applicable

Skills & Requirements

  • BS or BA in a scientific discipline and/or equivalent experience.  Advanced degree strongly desired
  • 12+ years of relevant regulatory affairs experience, including advertising & promotional materials experience in the pharmaceutical/biotechnology industry
  • Experience in managing/chairing teams accountable for reviewing advertising & promotions material (e.g., MLR); ability to effectively lead multidisciplinary team members 
  • Excellent knowledge and understanding of US regulations for drug promotion/advertising and US labeling; experience in leading the regulatory review of advertising and promotion material
  • Hands on experience in leading submission activities to OPDP
  • Experience with regulatory activities involved with a product launch
  • Prior experience in oncology drugs strongly preferred
  • Ability to collaborate and manage stakeholders to adhere to timelines and deadlines
  • Ability to interpret clinical and scientific data
  • Possesses strong interpersonal, collaboration and communication skills, and demonstrates flexibility in a dynamic environment
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