Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL)

About the role

The Associate Director, Regulatory Affairs Advertising, Promotion & Labeling (AD RA-APL) provides regulatory advertising and promotion guidance for compliant external communications. This role works closely with commercial/launch teams, medical affairs, research and development, corporate communications, and legal to ensure external communications, including but not limited to promotional communications, are compliant with regulatory requirements and align with strategic objectives and commercial regulatory strategy.

Responsibilities

• Develops innovative and compliant strategies to support advertising & promotion objectives
• Represents Regulatory on the Commercial Medical, Legal, Regulatory Committee (CMLR) to navigate claims and presentations, providing advice based on the Federal Food, Drug, & Cosmetic Act (FDCA) and implementing regulations impacting advertising & promotional labeling
• Interprets content of FDA regulations, guidance documents, and enforcement letters and communicates information to stakeholders in order to ensure compliant commercial materials
• Accountable for review and approval of materials for both promotion and scientific exchange, in line with relevant goals and deliverables with a broad impact on the organization
• Proposes creative, effective and compliant regulatory strategies and solutions to promotional concepts that meet business objectives and minimize risk
• Manages the FDA 2253 program, leading submission of branded promotional materials to FDA Advertising & Promotional Labeling Branch (APLB) and/or Office of Prescription Drug Promotion (OPDP) at time of initial dissemination by Commercial
• Represents Regulatory on the Medical Review Committee (MRC) and Scientific Communications Review Committee (SCRC)

Requirements

• Experience with developing product labeling and knowledge of labeling regulations a plus

Qualifications

• In-depth understanding of regulatory advertising and promotional labeling concepts
• Consistent track record of advising on successful business strategies for branded and unbranded promotional campaigns
• Strong ability to work independently, with flexibility, and to collaborate with stakeholders
• Previous working knowledge of FDA 2253 program
• Experience in managing complex projects. Demonstrated ability to work with people in a global, dynamic environment to deliver value-added results. Solid ability to recognize and escalate issues. Capable of dealing with ambiguity. Creative and comfortable working with multifunctional teams.
• Strong interpersonal skills. Proven negotiator and demonstrated ability to use constructive debate to identify and move others towards compliant promotional outcomes.
• Well organized with exceptional communication skills, strong influencing skills, strong technical writing and documentation skills, as well as strong analytical and problem-solving skills
• Proficient in computer applications and configurations including Microsoft Office Suite or related software, and electronic document management systems (e.g., Veeva Vault PromoMats and MedComms)
• Product launch experience is a plus
• BS degree in scientific, clinical or related area required. Advanced degree highly desirable.
• Regulatory Affairs Certification is a plus
• 6+ years pharmaceutical/biotech industry experience with a minimum of 4 years of direct experience as Regulatory reviewer of advertising and promotional materials is required.
• Demonstrated history of successful interactions with promotional review divisions of FDA (OPDP/APLB)
• Prolonged periods of sitting at a desk and working on a computer.

Skills

• Exceptional understanding of medical concepts and terminology
• Strong aptitude for use of electronic systems to support Regulatory reviews and submissions.

Benefits

N/A

Pay

$193,176.00 - $236,104.00 USD per year

Schedule

N/A