The Opportunity

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The function of a Regulatory Affairs Manager, Advertising & Promotion is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department / group / site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may analyze broad scope implications of changing regulations and guidance. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Responsible for providing regulatory guidance to shape and inform successful marketing campaigns and programs that range from traditional media to upcoming social media channels in established and emerging markets.This is a broad scoped position with strong opportunity for growth and career development based on performance.

Main Responsibilities

• Review advertising, promotional, corporate and other non-promotional materials for U.S. region to assess for compliance with the applicable regulations, guidance documents, and internal policies / best practices.
• Define regulatory advertising objectives to ensure campaigns are effective and appropriate for their intended audience.
• Liaise with managers in sales, marketing, and brand management to review campaigns that will help them achieve marketing and sales goals.
• Align with the organization's overall advertising and promotional strategy.
• Contribute to the review of marketing strategies for product, service, or market segment that align with the organization's vision and its current and long-term business objectives.
• Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Individual is recognized as a discipline expert and resource in regulatory affairs.
• Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.
• Must have in-depth knowledge of commercial regulatory requirements associated with Advertising and Promotion of medical devices. Utilize technical regulatory skills to propose strategies on complex issues.
• Must be capable of developing and implementing regulatory strategy and working closely with various stakeholders. Evaluate risk of regulatory standards to product and safety issues on advertising and promotional materials and recommend solutions.
• Support RA Ad & Promo management ensuring on time department deliverables and developing mitigation plans for any issues that are identified, including Ad & Promo process improvements.
• May lead a cross-functional or cross-divisional project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff developing their skills / abilities and assisting them in areas of efficiency and regulatory knowledge.
• Develop, communicate, and build consensus with various cross-functional depts (Marketing, Clinical / Scientific / Medical Affairs, Reimbursement, Legal & R&D) to be in alignment with the division and business goals. The role will require interfacing with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
• Creates immediate to long-range plans to carry out objectives established by top management. Assignments are expressed in the form of objectives. Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.
• Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.

Experience and Qualifications