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POSITION SUMMARY

The Director, Global Regulatory Affairs Advertising and Promotion provides strategic and operational regulatory leadership for all commercial regulatory activities, enabling the business to meet its commercial objectives  in a compliant and timely manner. This position will provide leadership as a key member of the Medical, Legal and Regulatory (MLR) and provides experienced regulatory guidance for the preparation, review, approval, and submission  of advertising and promotional materials..

The individual is expected to work with a high degree of independence, accountability, reliability, and follow-through; proactively identify and resolve issues; anticipate risks to timelines or execution; and drive assigned activities to completion with limited day-to-day supervision. Significant, novel, or precedent-setting matters should be escalated to senior Regulatory leadership, including a clear assessment of the issue, regulatory implications and risk, available options, and a recommended approach.

This role will report to the Senior Director, Global Regulatory Affairs Labeling.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for providing commercial regulatory leadership for assigned programs.
• Serve as a key Regulatory Advertising & Promotion subject-matter expert for advertising/promotional materials.
• Serve as regulatory liaison to the FDA/CDER/Office of Prescription Drug Promotion (OPDP) and other health agencies, as appropriate.
• Oversee or author commercial regulatory submissions and work closely with the Publishing vendor to ensure the timely submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
• Represent Commercial Regulatory Advertising and Promotion at labeling meetings and provide strategic regulatory guidance, as appropriate.
• Provide regulatory guidance on new concepts and new campaigns.
• Maintain current knowledge of applicable of FDA regulations, guidance documents, enforcement actions, and relevant regulatory precedents, and translate that knowledge into practical recommendations for the organization.
• Recognized as an expert resource for regulatory advice across departments.
• May contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.
• Responsible for the development and implementation of regulatory advertising and promotional processes, as necessary.
• Establish and maintain an effective tracking and planning system, including materials under review, upcoming deliverables, regulatory submissions, key milestones, deadlines, dependencies, and outstanding actions, to support visibility, prioritization, and timely execution.

QUALIFICATIONS

Education /Experience:

• Bachelor's or advanced degree in a scientific discipline, with a minimum of 10-12 years in Regulatory Affairs with a minimum of 10 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products
• Demonstrated experience reviewing promotional and non-promotional materials in an MLR environment.
• Direct experience with the FDA's Office of Prescription Drug Promotion (OPDP), including promotional material submissions and regulatory strategy.
• Experience representing Commercial Regulatory Affairs on cross functional teams is desirable.
• Experience with prescription drug labeling, including familiarity with USPI and/or global labeling documents, is preferred.
• Excellent planning and organizational skills, with a demonstrated ability to independently manage multiple projects and competing priorities..
• Excellent communication skills both in writing and verbally.

 Knowledge, Skills and Abilities:

• Direct experience with FDA's Office of Prescription Drug Promotion (OPDP) submissions and strategies.
• Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products is required.
• Knowledge of and experience with laws and regulations regarding marketing pharmaceuticals in rest of world (ROW) is highly desired.
• Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
• Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions.
• Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others.
• Ability to engage and manage multiple stakeholders to achieve the business objective.
• Operationally excellent.
• Organized with systematic approach to prioritization.
• Process oriented to achieve the business objective.

 Work Environment:

• This is a high growth, fast paced organization. The ability to be productive and successful in a dynamic work environment is critical.
• Some travel may be required. Responsibilities may require a work schedule that includes working outside of "normal" business hours, to meet business demands of a global company.

The salary range for this position is $240,000 to $260,000USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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