Director, Regulatory Affairs Advertising and Promotion

About the role

The director leads the Materials Review Committee and guides cross-functional teams. The position demands advanced regulatory expertise and alignment with company objectives.

Leaders set direction and build the conditions for their teams to succeed. They hire, coach, and hold people accountable. Leadership work spans strategy, communication, and decision making. Effective leaders give clear context and remove obstacles for the people who report to them. Leadership roles are measured by team outcomes, retention, and delivery. Most organizations expect leaders to be visible, predictable, and generous with context.

Key facts

What you'll do

Regulatory review of advertising and promotional materials for U.S. and Canada is conducted by a subject matter expert.

The Materials Review Committee is chaired and regulatory strategy for communications across the product life cycle is directed.

Form FDA-2253 submissions are reviewed to ensure compliance with promotional regulations.

U.S. and Canada commercial and medical teams are supported during strategy discussions and meetings.

Cross-functional process improvements or special projects are led when requested.

Regulatory sub-team and labeling meetings are represented, and strategic regulatory guidance is delivered.

Other duties as required are fulfilled to meet role expectations.

Requirements

A BA/BS degree is required; an advanced degree in PharmD, PhD, MS, MBA, or JD is preferred.

Industry experience of 10+ years, including 5+ years in advertising and promotion, is required.

Excellent verbal and written communication skills are required.

Attention to detail and the ability to manage multiple priorities simultaneously are required.

Strong interpersonal skills and strategic, analytical thinking are demonstrated.

Transparent collaboration is practiced to encourage engagement and respectful interactions.

Review committee leadership or participation in regulatory governance bodies is expected.

Experience in cross-functional projects and teams is required.

Proficiency with Veeva PromoMats for promotional materials management is preferred.

Travel is performed when necessary for role requirements.

Practical notes

Work is fully remote with documented home-based arrangements, and occasional travel to offices may occur.

Benefits include generous vacation, public holidays, volunteer days, long-term incentives, employee stock purchase plans, wellbeing programs, fitness reimbursement, tuition sponsoring, and professional development plans.

Equal opportunity applies; reasonable accommodations are provided for protected statuses.

Typical interview steps

Leadership hiring usually includes a strategy case, a people scenario, and a values conversation. Candidates may be asked to turn around a struggling team or plan for growth. Past results are examined closely, especially how decisions were made. Interviewers dig into specific decisions you made and their consequences. Preparing two or three decision stories with numbers and lessons is the best use of time.

Good to know

The role focuses on regulatory affairs for advertising and promotion in a rare disease biopharma setting.

It involves frequent interaction with regulatory agencies and cross-functional stakeholders.

The position uses specialized tools such as Veeva PromoMats for promotional content management.

Success requires strategic thinking, detailed regulatory knowledge, and collaborative problem solving.

The role supports patient impact through compliant and timely material approvals.

Questions to ask

Good questions to ask the employer in the interview: what does success look like in the first six months, how is the team structured, what is the current biggest challenge, and how are decisions made. Asking about growth paths and the review process is also well received. Employers expect questions, and good ones show preparation.

Career growth

Leadership careers move from manager to senior manager, director, and executive roles. Each step adds more scope and more responsibility for outcomes. The best leaders keep learning how to delegate, communicate, and decide. Leadership careers reward a record of building and developing people. The higher you go, the more your communication shapes the whole organization.