Director, US Advertising and Promotion

The businesses of Merck KGaA, Darmstadt, Germany•Boston, MA

7h•$210,900 - $316,300•Remote

About The Position

The Director, US Advertising and Promotion serves as the U.S. promotional regulatory lead for assigned products and is accountable for review, approval, and strategic oversight of promotional materials. The Director ensures compliance with applicable laws, regulations, and FDA guidance while providing independent regulatory counsel to cross-functional stakeholders. Operating with a high degree of autonomy, the role enables compliant and effective promotional strategies that support business objectives. The Director leads and represents Regulatory Affairs on Promotional Review Committees, ensuring 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 proposes compliant regulatory strategies and solutions to complex promotional concepts while balancing business objectives with regulatory risk. The role 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 Director drives the development, implementation, and continuous improvement of advertising and promotion processes, standards, and standard operating procedures. The Director assesses evolving regulatory trends, guidance, and enforcement activities and advises Regulatory Affairs teams, review committees, and cross-functional stakeholders. The Director participates in labeling and global regulatory team discussions to align clinical development and labeling strategies with anticipated promotional claims and messaging. Responsibilities also include developing regulatory strategy communications, including responses to FDA action letters, overseeing interactions with OPDP and APLB, and overseeing enterprise-wide training on promotional regulatory requirements. As a strategic leader, the Director collaborates with Marketing, Legal, Medical Affairs, Quality, and other stakeholders to enable compliant promotional execution. The role partners with Quality on internal audits and CAPAs and provides regulatory leadership to support compliance and continuous improvement. As a U.S. promotional regulations subject matter expert, the Director provides coaching and informal mentorship, including onboarding support for new hires.

Requirements

Bachelor’s degree in a science or health-related discipline.
Minimum 8 years of pharmaceutical industry or related experience.
At least 5 years as a primary reviewer of advertising and promotional materials.
In-depth knowledge of FDA regulations governing prescription drug promotional materials, including OPDP and APLB processes.
Demonstrated ability to identify and deliver solutions to complex promotional regulatory challenges while balancing business objectives with regulatory risk.
Strong diplomacy, interpersonal, and negotiation skills, with a track record of building consensus across cross-functional teams.
External applicants must be eligible to work in the United States; the role does not offer work authorization sponsorship.

Nice To Haves

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

Responsibilities

Serve as the U.S. promotional regulatory lead for assigned products and oversee review, approval, and strategic oversight of promotional materials.
Ensure promotional materials comply with applicable laws, regulations, and FDA guidance, and provide independent regulatory counsel to stakeholders.
Lead and represent Regulatory Affairs on Promotional Review Committees.
Serve as the primary regulatory liaison to FDA promotional review divisions, including OPDP and APLB; manage correspondence, address regulatory inquiries, and oversee submissions for advisory comment.
Develop innovative, compliant regulatory strategies and solutions for complex promotional concepts while balancing business objectives and regulatory risk.
Lead evaluation and regulatory positioning of proposed product claims for assets in development, including oversight of ISI and Brief Summary documents as appropriate.
Develop, implement, and continuously improve advertising and promotion processes, standards, and standard operating procedures.
Assess evolving regulatory trends, guidance, and enforcement activities and advise relevant teams and stakeholders.
Participate in labeling and global regulatory discussions to align clinical development and labeling strategies with anticipated promotional claims and messaging.
Lead development of regulatory strategy communications, including responses to FDA action letters, and oversee interactions with OPDP and APLB.
Oversee enterprise-wide training on promotional regulatory requirements.
Collaborate with Marketing, Legal, Medical Affairs, Quality, and other stakeholders on compliant promotional execution.
Partner with Quality on internal audits and CAPAs, providing regulatory leadership to support compliance and continuous improvement.
Provide coaching, informal mentorship, and onboarding support to team members and new hires.