Associate Director Of Regulatory Affairs Advertising And Promotion

Icon; Johannesburg; On-site; ZAR 900 000 - 1 500 000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking an Associate Director for Regulatory Affairs Advertising & Promotion. This role involves providing strategic regulatory advice, ensuring compliance with US laws, and overseeing promotional materials. The ideal candidate will have extensive experience in regulatory affairs and a strong understanding of advertising regulations, along with excellent communication skills to collaborate with cross-functional teams.

Qualifications

• 6+ years of relevant pharmaceutical industry experience.
• 4+ years of prescription product advertising and promotion review experience.
• Ability to maintain collaborative relations with cross-functional teams.

Responsibilities

• Provide regulatory strategic oversight for complex products.
• Participate in multidisciplinary review teams for product communications.
• Monitor US regulatory promotional environment and ensure compliance.

Skills

Strategic thinking

Innovative problem-solving

Interpersonal communication

Analytical skills

Education

Bachelor's degree in science or health-related discipline

PhD, MS, PharmD, JD (preferred)

Tools

Veeva PromoMats

Job description

The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational, and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products, ensuring compliance with US laws, regulations, and company policies.

This role supports the achievement of business objectives and provides regulatory review of advertising and promotional labeling, disease awareness and training materials, new campaigns, and product launch strategies.

What you will be doing :

Serve as subject matter expert on FDA regulations and OPDP guidance governing promotion and prescription drug / biologic products and disease awareness activities.

Participate on multidisciplinary medical, legal, and regulatory review teams with responsibility for review, risk assessment, and regulatory decisions regarding product communications.

Provide regulatory strategic oversight for at least one complex product or therapeutic area / multiple products, including management of Form submissions.

Ensure US Prescribing Information (USPI) is accurately applied to external communications and updated promptly as needed.

Monitor and keep the organization informed about the US regulatory promotional environment, including new FDA regulations, guidance, enforcement actions, and industry practices.

Contribute to a culture of compliance by participating in training personnel on promotional, marketing, labeling, and advertising regulations and updates.

Required Skills and Qualifications :

Ability to maintain collaborative, efficient, and effective working relations with cross-functional teams (commercial, medical, legal, regulatory).

Strong interpersonal, oral, and written communication skills.

Understanding of business goals and marketing concepts / tools.

High degree of professionalism, ethics, integrity, and responsibility.

Flexibility and openness to change in a growing, multicultural environment.

Strategic thinking and innovative problem-solving skills, with a team-oriented approach.

Comfort in a fast-paced, results-driven, and highly accountable environment.

Analytical and problem-solving skills to understand complex issues and propose solutions.

Working knowledge of Veeva PromoMats.

Availability to attend occasional meetings in Boston, MA, including overnight stays, as needed.

Minimum Qualifications :

Bachelor's degree in science or health-related discipline; advanced degrees (PhD, MS, PharmD, JD) preferred.

6+ years of relevant pharmaceutical industry experience.

4+ years of prescription product advertising and promotion review experience, with broad knowledge of pharmaceutical regulatory affairs.

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