This role will be considered at the Associate Director and Director level.
The Associate Director / Director, International Regulatory Advertising Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. Designs and delivers optimized global regulatory strategies, plans and dossiers that align with AbbVie’s overall business strategy. 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. Leads the international regulatory strategy for the assigned marketed and development compounds. Interface with International Marketing, Global Legal and Office of Ethics and Compliance with regard to advertising and promotion strategies and tactics intended for use globally.
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 effecting 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 often 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 program. Negotiates/resolves the majority of decisions with Marketing, Medical Legal,
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. Constantly searches for out of the box solutions while maintaining quality and adherence to regulations.
Balances business needs and risk assessments with creative decision-making abilities. Responsible for assigned marketed and development compounds advertising and promotion strategies. Has accountability for: the sound representation of global Regulatory Advertising and Promotion position within and external to AbbVie; and the operations, initiatives, and strategies for the regulatory Advertising and Promotion department.
Leads cross-functional/ multidisciplinary/therapeutic teams Demonstrates compliance with international codes of practice relevant regulations, and manages financial business goals.
5+ years of pharmaceutical experience a minimum of 3 years advertising and promotion regulatory experience preferred but may consider medical/scientific affairs with a of minimum 5 years direct advertising and promotion review experience.
Minimum Bachelor's Degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), is required
The candidate must have a solid understanding of regulatory advertising and promotion regulations, having had direct responsibility in this area.
Master’s, Ph.D or Pharm D preferred
International experience desired but not required
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
