Medical Affairs Associate Jobs in Raleigh, NC (NOW HIRING)

Job Summary:

The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across various communication channels. This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic regulatory guidance on advertising and promotional activities. The ideal candidate will have expertise in FDA regulations, OPDP (Office of Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry best practices.

Key Responsibilities:

Regulatory Compliance & Review:

• Review and approve promotional materials, corporate communications, and disease awareness campaigns to ensure compliance with FDA and other applicable regulatory requirements.
• Guide promotional strategy as the Regulatory Ad Promo representative during early stages of product development
• Maintain up-to-date knowledge of regulatory requirements, enforcement trends, and industry best practices.

Cross-Functional Collaboration:

• Lead discussions for assigned products during the Promotional Material Review Team (PMRT) and Medical Review Committee (MRC) working closely with Marketing, Medical, Legal, and Compliance teams to develop impactful material that aligns with regulatory expectations.

Health Authority Interactions:

• Support interactions with the FDA's Advertising and Promotional Labeling Branch (APLB) and other regulatory authorities as needed.
• Prepare regulatory submissions for promotional materials, including 2253 filings and advisory comments requests.
• Address regulatory queries from health authorities regarding promotional and advertising content.

Training & Process Improvement:

• Develop and deliver training programs on promotional regulations for internal stakeholders.
• Help refine internal SOPs, best practices, and review processes for advertising and promotion compliance.
• Monitor and analyze enforcement actions and industry trends to proactively mitigate regulatory risks.

Qualifications & Experience:

Education:

• Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline).
• Advanced degree (PharmD, JD, or Master's in Regulatory Affairs) preferred.

Experience:

• Minimum 5 years of experience in Regulatory Affairs, with at least 2 years focused on advertising and promotion in the pharmaceutical, biotech, or medical device industry.
• Strong knowledge of applicable regulations and enforcement trends
• Prior experience working with cross-functional review committees in a regulated environment.
• Global regulatory knowledge (EMA, Health Canada, UK etc.) is a plus.

Skills & Competencies:

• Deep understanding of US and global regulatory frameworks for advertising and promotion.
• Excellent ability to interpret and apply regulatory guidelines and requirements in a business-focused, solutions-oriented manner.
• Strong written and verbal communication skills, with experience in preparing regulatory documentation.
• Ability to work cross-functionally and manage multiple projects in a fast-paced environment.
• Strong attention to detail and problem-solving skills.

Preferred Qualifications:

• Familiarity with digital and social media promotional compliance.
• Experience in infectious diseases, oncology, rare diseases, and/or vaccines is a plus.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.