POSITION SUMMARY

The Associate Director, Regulatory Affairs Advertising and Promotion provides regulatory guidance on commercial regulatory activities to enable the business to meet its commercial needs in a compliant manner. This position will provide regulatory guidance as a member of the Medical, Legal and Regulatory (MLR). This role is accountable for helping develop strategies and timelines, and managing internal team discussions to support preparation of advertising and promotional materials for regulatory submissions. This role will report to the Director, Global Regulatory Affairs Advertising and Promotion.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for providing commercial regulatory oversight for assigned programs.
• Manage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
• Provide regulatory guidance on new concepts and new campaigns.
• Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Help monitor enforcement trends and provide timely advice to the team.
• Recognized as a resource for commercial regulatory advice across departments.
• May contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.
• Aid in the development and implementation of regulatory advertising and promotional processes, as necessary.

QUALIFICATIONS

Education /Experience:

• Bachelor’s or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products.
• Experience representing Commercial Regulatory Affairs on cross functional teams is desirable.
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Excellent communication skills both in writing and verbally.

Knowledge, Skills and Abilities:

• Experience with FDA’s Office of Prescription Drug Promotion (OPDP) submissions and strategies.
• 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 influence others.
• Ability to engage multiple stakeholders to achieve the business objective.
• 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 work environment is critical.
• Some travel required. Responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands of a global company.

The salary range for this position is $205,000 to $225,000 USD. 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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