Director, Regulatory Advertising and Promotion

Merck•Boston, MA

1d•Hybrid

About The Position

At the intersection of science, strategy, and compliance, this role offers a rare opportunity to shape how life-changing therapies are brought to patients through compliant, compelling promotion. The Director, Advertising and Promotion serves as the U.S. promotional regulatory lead for assigned products and is accountable for the review, approval, and strategic oversight of promotional materials. In this role, the Director ensures compliance with applicable laws, regulations, and FDA guidance while providing independent, expert regulatory counsel to cross-functional stakeholders. Operating with a high degree of autonomy, the Director enables the development of compliant and effective promotional strategies that support business objectives and drive organizational success. The Director leads and represents Regulatory Affairs on Promotional Review Committees, ensuring that U.S. promotional materials for prescription products meet regulatory requirements and align with company strategy. As the primary regulatory liaison to FDA promotional review divisions, including OPDP and APLB, the Director manages correspondence, addresses complex regulatory inquiries, and oversees submissions for advisory comment. The role requires the ability to propose innovative and compliant regulatory strategies and solutions to complex promotional concepts, balancing business objectives with regulatory risk. In addition, the Director leads the strategic evaluation and regulatory positioning of proposed product claims for assets in development, including oversight of Important Safety Information (ISI) and Brief Summary documents, as appropriate. The role drives the development, implementation, and continuous improvement of advertising and promotion processes, standards, and standard operating procedures to enhance operational efficiency and ensure sustained regulatory compliance. The Director also leads the assessment of evolving regulatory trends, guidance, and enforcement activities, proactively advising Regulatory Affairs teams, review committees, and cross-functional stakeholders to inform business decisions and ensure compliance. The Director actively participates in labeling and global regulatory team discussions to ensure alignment of clinical development and labeling strategies with anticipated promotional claims and messaging. The role includes leading the development of regulatory strategy communications, including responses to FDA action letters, and overseeing interactions with OPDP and APLB. The Director also oversees the design and execution of enterprise-wide training on promotional regulatory requirements to strengthen organizational capability and compliance awareness. As a key strategic leader, the Director collaborates closely with Marketing, Legal, Medical Affairs, Quality, and other stakeholders to enable compliant and effective promotional execution. The role partners with Quality on internal audits and CAPAs, providing regulatory leadership to ensure alignment with compliance requirements and to drive continuous improvement. Recognized as a subject matter expert in U.S. promotional regulations, the Director provides coaching and informal mentorship to team members, including onboarding support for new hires, fostering a culture of consistency, capability development, and regulatory excellence.

Requirements

Bachelor’s degree in a science or health-related discipline.
Minimum 8+ years of pharmaceutical industry or related experience.
Minimum of 5 years as a primary reviewer of advertising and promotional materials.
In-depth knowledge of FDA regulations governing the development, review, and approval of prescription drug promotional materials, including OPDP and APLB processes.
Demonstrated ability to identify and deliver solutions to complex promotional regulatory challenges, balancing business objectives with regulatory risk.
Strong diplomacy, interpersonal, and negotiation skills, with a track record as a consensus builder across cross-functional teams.
External applicants must be eligible to work in the US.

Nice To Haves

Advanced degree (PhD, MD, MS, or PharmD) strongly preferred.
Experience leading or supporting drug promotion activities and product launches within a pharmaceutical or biopharmaceutical environment.
Comprehensive understanding of the Regulatory Affairs landscape for prescription drugs, including labeling strategy and clinical development alignment.
Demonstrated ability to lead enterprise-wide training initiatives and foster a culture of continuous improvement and regulatory compliance.
Excellent verbal and written communication skills, with the ability to translate complex regulatory concepts for diverse audiences.

Responsibilities

Serves as the U.S. promotional regulatory lead for assigned products.
Accountable for the review, approval, and strategic oversight of promotional materials.
Ensures compliance with applicable laws, regulations, and FDA guidance.
Provides independent, expert regulatory counsel to cross-functional stakeholders.
Enables the development of compliant and effective promotional strategies.
Leads and represents Regulatory Affairs on Promotional Review Committees.
Manages correspondence, addresses complex regulatory inquiries, and oversees submissions for advisory comment with FDA promotional review divisions (OPDP and APLB).
Proposes innovative and compliant regulatory strategies and solutions to complex promotional concepts.
Leads the strategic evaluation and regulatory positioning of proposed product claims for assets in development.
Oversight of Important Safety Information (ISI) and Brief Summary documents.
Drives the development, implementation, and continuous improvement of advertising and promotion processes, standards, and standard operating procedures.
Leads the assessment of evolving regulatory trends, guidance, and enforcement activities.
Actively participates in labeling and global regulatory team discussions.
Leads the development of regulatory strategy communications, including responses to FDA action letters.
Oversees the design and execution of enterprise-wide training on promotional regulatory requirements.
Collaborates closely with Marketing, Legal, Medical Affairs, Quality, and other stakeholders.
Partners with Quality on internal audits and CAPAs.
Provides coaching and informal mentorship to team members, including onboarding support for new hires.