Jobs · OTHR · Illinois

Associate Director, International Regulatory Affairs Advertising & Promotion-Hybrid

BioSpace · Mettawa, IL · 3 wk ago
OTHRFull-time

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience—and products and services in our Allergan Aesthetics portfolio.

About the role

The Associate Director, International Regulatory Affairs Advertising & Promotions safeguards products and practices to adhere to the highest quality and regulatory standards. This role is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan. The Associate Director leads the international regulatory strategy for assigned marketed and development compounds and interfaces with International Marketing, International Medical Affairs, Global Legal, and the Office of Ethics and Compliance regarding advertising and promotion strategies and tactics intended for global use.

This role requires a hybrid work schedule—3 days in office from our AbbVie Mettawa, IL headquarters.

Responsibilities

  • Reviews and evaluates the global industry environment (e.g., regulatory, legal, and political climate) and plans strategically for overall system of regulatory communications.
  • Provides functional input on key initiatives impacting other areas.
  • Leads the implementation of risk management strategies and risk management plans for global Regulatory advertising and promotion.
  • Provides global regulatory position, perspective, and expertise related to advertising and promotion to internal and external customers/business partners.
  • Maintains current knowledge of global codes of practice, regulations, and guidances that impact pharmaceutical advertising and promotion.
  • Has direct international (ex-US) accountability for assigned therapeutic areas within the Regulatory Advertising and Promotion department.
  • Implements department policies and procedures and significantly contributes to the development and updates to Divisional and Corporate policies affecting global core messaging.
  • Supports departmental and business strategies, quality initiatives, compliance with policies and procedures, and the implementation of improvement plans.
  • Contributes to the evaluation of departmental needs and implements solutions to enhance and facilitate operations.
  • Provides critical analysis and potential interpretations of the regulatory position and messaging for communications in response to highly visible pharmaceutical news having political, financial, and legal interests.
  • Creates an environment to attract, retain, empower, and mentor leaders in business knowledge, management skills, and continued development.
  • Provides strategic input into comprehensive training programs.
  • Negotiates/resolves decisions with Marketing, Medical, Legal, Public Affairs, and compliance counterparts.
  • Collaborates and communicates effectively through all levels of management across multiple divisions and functions.
  • Is recognized by organizational counterparts as a key company resource on pharmaceutical advertising and promotion.
  • Applies novel and creative methods to problem-solving while maintaining quality and adherence to regulations.
  • Balances business needs and risk assessments with creative decision-making abilities.
  • Leads cross-functional/multidisciplinary/therapeutic teams.
  • Demonstrates compliance with international codes of practice, relevant regulations, and manages financial business goals.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.

Qualifications

  • Minimum bachelor’s degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) is required. Masters, Ph.D., or Pharm D preferred.
  • Associate Director: 8+ years of pharmaceutical experience with a Bachelor’s, 5+ years with a Pharm D plus relevant ad/promo experience.
  • The candidate must have a solid understanding of regulatory advertising and promotion regulations, having had direct responsibility in this area.
  • International experience desired but not required.

Benefits

  • Comprehensive package of benefits including paid time off (vacation, holidays, sick).
  • Medical/dental/vision insurance.
  • 401(k) to eligible employees.
  • Eligibility to participate in long-term incentive programs.

Pay

The compensation range for this role is based on the job grade and may vary depending on geographic location. The range may be modified in the future. Individual compensation paid within this range will depend on several factors, including location.

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