Director, International Regulatory Affairs Advertising and Promotion

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

The 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.
Qualifications
5-7 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
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.