Quality Recruiting. Established Experts.

Senior Director, Regulatory Affairs - Labeling Advertising/Promotion

Reference Number: 2810
Location: Northeast

Our client is one of the world’s leading generics and specialty pharmaceutical companies.  They have asked us to assist them in their search for a Senior Director, Regulatory Affairs - Labeling Advertising/Promotion.

Major tasks and responsibilities will include:

  • Provides strategic leadership and oversight to Labeling and Advertising/Promotion activities within the NA region.
  • While working in a highly matrix environment, ensures all deliverables encompassed within the labeling processes are effectively executed for all products as well as applies critical review skills and creative solutions to diverse promotional scenarios.
  • Implements strategies being deployed by the Global COE for Labeling and Advertising/Promotion to maintain an efficient and compliant process for review of advertising/promotional materials and other labeling materials.
  • Ensures the team consistently delivers high-quality product labeling and services commensurate with global regulatory requirements, business priorities and compliance obligations.
  • Communicates/negotiates directly with the FDA on advertising and promotional material and labeling-related activities. Leverages expertise within other NA countries to communicate with other health authorities in NA (e.g., Health Canada).
  • Maintains effective partnerships with internal business stakeholders including, but not limited to Global Regulatory Leaders, Medical Affairs, Product Safety, Legal, Marketing, and Business Development to shape labeling and AdProm strategies.
  • Reviews and comments emerging internal and external guidelines and regulations on regulatory, safety, and legal topics related to labeling, Promotion & Advertising, within the NA region and provides input into the global COE regarding these guidance.
  • Effectively partners with Global Regulatory Policy and Intelligence group to better leverage future regulations relevant to product labeling and AdProm material as well as its delivery to healthcare providers and patients.
  • Accountability for deploying the global framework of processes and systems as well as utilize the global governance to support the development, review and approval of product labeling.
  • Develops and implements mechanisms to monitor the organizational performance of the team through metrics that will lead to continuous improvement and innovation.
  • Develops and manages a highly competent and technically skilled organization of direct reports that are completing activities related to labeling and Advertising and Promotion.

We seek candidates with the following qualifications:

  • A Bachelor’s degree (or equivalent) and a minimum of 10 years of relevant industry experience is required.  A degree in a scientific discipline is strongly preferred.  An Advanced degree (MS, PhD, MD) in a scientific discipline is a plus.
  • A minimum of 8 years of experience in Regulatory Affairs with Subject Matter Expertise in either labeling or AdProm.  However, a combination of experience and/or education will be taken into consideration.
  • Experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
  • Ability to maintain a high level of engagement, instill a sense of teamwork and exploit opportunities to innovate.
  • Demonstrated success leading interdisciplinary teams on promotional materials and labeling activities.
  • Must demonstrate a high level of self-awareness and adaptability. Must be resilient, willing to learn from others, optimistic, flexible and adaptable.
  • A track record of effective change management and transition management is strongly preferred.
  • The ability to develop and execute efficient processes and provide global oversight is required.
  • Exceptional communication, negotiation and partnering skills are a must. Must be an influential, visionary, people leader with a demonstrated track record of people development.
  • Understanding of pharmaceutical product development and a solid understanding of biology and pharmacology.
  • Preferred strong experiences and working relationships within European health authorities both centrally and nationally.
  • Experience reading, understanding, and applying regulations to constantly changing environment.
  • Ability to independently develop a course of action leading to a beneficial outcome.
  • Ability to apply continuous process improvement methodologies.
  • Strong knowledge and interest in the evolving landscape within regulatory guidance in reference to labeling and AdProm regulations.
  • Demonstrated ability to identify emerging issues and initiate actions to recommend solutions, including in areas of ambiguity.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2810. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.