Senior Director Regulatory Affairs, US Advertising and Promotion

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

2d•$258,300 - $387,500•Hybrid

About The Position

The Senior Director manages a team of promotional regulatory professionals in the review and approval of U.S. promotional materials, ensuring high-quality and compliant execution. Demonstrates strong promotional regulatory expertise and provides strategic input to support promotional review activities for prescription drug products. Ensures all promotional materials comply with applicable laws, regulations, and regulatory agency guidance, including FDA requirements, and supports the development of compliant and effective promotional strategies. Provides oversight and guidance across multiple therapeutic areas, with the ability to assess and make sound regulatory decisions on complex promotional regulatory issues. Drives alignment and facilitates effective collaboration with U.S. Marketing leadership to support business objectives while maintaining regulatory compliance.

Requirements

Bachelor’s degree in science or health related discipline.
Minimum 10 or more years of pharmaceutical industry or related experience with an emphasis in regulatory or scientific disciplines, with a minimum of seven years of direct experience as the primary reviewer of advertising and promotional materials.
Ability to provide supervision and support across multiple therapeutic areas.
Demonstrated ability to make day-to-day regulatory decisions for escalations.
Demonstrated in-depth expertise in FDA regulations governing promotion development, implementation, and promotional review processes, with the ability to shape organizational interpretation and application.
Comprehensive understanding of the clinical development lifecycle, regulatory policy, labeling strategy, and FDA approval processes, applied to inform and guide cross-functional strategic decisions.
Proven ability to lead and resolve highly complex promotional regulatory challenges, driving innovative, compliant solutions across products and therapeutic areas.
Exceptional diplomacy, influence, and negotiation skills, recognized for building consensus and effectively engaging senior stakeholders; demonstrated strategic and analytical leadership in shaping business and regulatory outcomes.

Nice To Haves

Advanced degree (PhD, MD, MS, PharmD) highly preferred.
Experience supporting or leading drug promotion activities and product launches, with a solid understanding of commercialization and regulatory considerations across the product lifecycle.
Comprehensive understanding of the pharmaceutical Regulatory Affairs landscape, including prescription drug promotion and labeling requirements.
Demonstrated ability to lead and foster a culture of continuous learning, operational excellence, and process improvement within a matrixed organization.

Responsibilities

Build, lead, and mentor a high-performing U.S. regulatory Ad/Promo team.
Shape and advance regulatory strategy and solutions governing U.S. advertising and promotion to enable sustained compliance with evolving regulatory requirements and alignment with Company policy and business priorities
Manage interactions and correspondence with FDA’s promotional review divisions (OPDP and APLB), including addressing complex questions and overseeing submissions for advisory comment.
Shape regulatory strategy and provide expert oversight on proposed product claims for assets in development, ensuring scientifically sound and compliant messaging, and guiding (or oversees) the development of Important Safety Information (ISI) and Brief Summary documents, as appropriate.
Establish and advance the strategic framework for advertising and promotion processes and SOPs, driving continuous improvement to enhance operational efficiency and ensure sustained regulatory compliance
Provide strategic leadership in monitoring and interpreting regulatory developments, guidance, and enforcement trends, and ensure timely dissemination of actionable insights to Regulatory Affairs teams, review committees, and cross-functional partners to inform compliant business decisions.
Lead the evaluation of emerging regulatory trends, guidance, and enforcement activities, and proactively shapes organizational understanding by advising Regulatory Affairs, review leadership, and cross-functional stakeholders on regulatory and policy implications within OPDP and APLB, and the broader regulatory landscape to support informed, compliant decision-making.
Drive strategic integration between labeling and promotional regulatory activities by partnering with the Regulatory Affairs labeling group to assess the impact of package insert changes on product promotion and overall communication strategy.
Negotiate and influence business unit decisions by driving consensus with review and commercial leadership.
Oversee and supports the execution of company-wide training on regulatory requirements for product promotion, ensuring ongoing skills development and compliance awareness across the organization.
Provide strategic regulatory leadership as a core member of cross-functional promotional review teams, influencing key stakeholders across marketing, legal, medical, and regulatory functions to achieve compliant and business-aligned promotional outcomes.
Drive the development and evolution of advertising and promotion processes and procedures, shaping best practices and governance to support compliant and effective promotional activities across the organization.
Lead cross-functional collaboration with Quality on internal audits and CAPA activities, ensuring regulatory alignment and driving effective resolution of compliance findings.