Senior Manager, Regulatory Affairs Advertising and Promotion

PRA HEALTH SCIENCES; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

An established industry player is seeking an Associate Director for Regulatory Affairs Advertising & Promotion. This pivotal role involves providing strategic regulatory advice to ensure compliance with US laws and regulations while supporting the business's objectives. You will be the expert on FDA regulations, guiding cross-functional teams in the review of promotional materials and product communications. The position offers a dynamic and collaborative work environment, with opportunities for professional growth and a commitment to diversity and inclusion. Join a company that values your contributions and offers a competitive salary along with a range of benefits focused on your well-being.

Benefits

Annual leave entitlements

Health insurance options

Retirement planning options

Global Employee Assistance Programme

Life assurance

Flexible country-specific benefits

Qualifications

• 6+ years in pharmaceutical industry with focus on advertising and promotion.
• Ability to collaborate with cross-functional teams effectively.

Responsibilities

• Provide regulatory oversight for promotional materials and communications.
• Serve as a subject matter expert on FDA regulations.

Skills

FDA regulations knowledge

Interpersonal communication

Analytical skills

Problem-solving skills

Strategic thinking

Education

Bachelor's degree in science or health-related discipline

PhD, MS, PharmD, or JD (preferred)

Tools

Veeva PromoMats

Job description

Overview

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

Responsibilities

What you will be doing:

1. Serve as a subject matter expert on FDA regulations and OPDP guidance governing promotion, prescription drug/biologic products, and disease awareness activities.
2. Participate in multidisciplinary medical, legal, and regulatory review teams, with responsibility for review, risk assessment, and regulatory decisions regarding product communications.
3. Provide regulatory strategic oversight for at least one complex product or therapeutic area/multiple products, ensuring regulatory compliance of promotional and non-promotional materials, including management of Form 2253 submissions.
4. Ensure that US Prescribing Information (USPI) is accurately and appropriately applied to external communications and that changes to USPI are incorporated promptly.
5. Monitor and keep the organization informed about the US regulatory promotional environment, including new FDA regulations, guidance documents, enforcement actions, and industry practices.
6. Contribute to a culture of compliance by participating in training personnel on promotional, marketing, labeling, and advertising regulations and updates.

Qualifications

1. Ability to maintain collaborative, efficient, and effective working relations with cross-functional teams (commercial, medical, legal, regulatory).
2. Strong interpersonal, oral, and written communication skills.
3. Understanding of business goals and marketing concepts/tools.
4. High degree of professional ethics, integrity, and responsibility.
5. Flexibility and openness to change in a growing, multicultural environment.
6. Strategic thinking and proposing innovative solutions involving regulatory issues, with a team-oriented approach.
7. Comfortable in a fast-paced, results-driven, and highly accountable work environment.
8. Analytical and problem-solving skills to understand complex issues and propose solutions.
9. Working knowledge of Veeva PromoMats.
10. While this position is remote, occasional attendance at meetings in Boston, MA, may be required, including overnight stays.

Minimum Qualifications

1. Bachelor's degree in science or health-related discipline (advanced degrees [PhD, MS, PharmD, JD] preferred).
2. 6+ years of relevant pharmaceutical industry experience.
3. 4+ years of relevant prescription product advertising and promotion review experience, with broad knowledge of pharmaceutical regulatory affairs for prescription drugs.

What ICON can offer you

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme with TELUS Health
• Life assurance
• Flexible country-specific benefits such as childcare vouchers, bike schemes, gym memberships, travel passes, and health assessments

Visit our careers website to learn more about working at ICON: https://careers.iconplc.com/benefits

Our Commitment to Inclusion & Belonging

ICON is dedicated to providing an inclusive and accessible environment for all candidates. We are committed to a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For accommodations, visit: https://careers.iconplc.com/reasonable-accommodations

We encourage you to apply even if you do not meet all the requirements; you might still be the right fit for this or other roles at ICON.