Senior Director, Regulatory Advertising and Promotion

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

2d•$210,900 - $316,300•Hybrid

About The Position

The Senior Director, Advertising and Promotion serves as the strategic regulatory leader for U.S. promotional activities across assigned products or portfolio, accountable for the oversight, governance, and direction of promotional review and approval processes. This role ensures enterprise-level compliance with applicable laws, regulations, and FDA guidance while shaping forward-looking promotional regulatory strategies. As a senior advisor, this individual provides authoritative guidance to cross-functional leadership and influences key business decisions. Operating with significant autonomy, the Senior Director drives alignment, fosters a culture of compliance, and enables the development of innovative, compliant promotional strategies that advance organizational objectives.

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.
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.
External applicants must be eligible to work in the US.

Nice To Haves

Advanced degree (PhD, MD, MS, PharmD) highly preferred.
Experienced leading or supporting drug promotion and product launches is preferred.
Comprehensive understanding of the pharmaceutical industry Regulatory Affairs landscape prescription drugs and labeling considerations.
Demonstrated ability to lead and foster a culture of continuous learning and process improvement across the organization.

Responsibilities

Provide cross-functional leadership and representation for Regulatory Affairs on Promotional Review Committees, ensuring U.S. promotional materials are compliant with regulatory requirements while shaping and aligning with overarching corporate and portfolio strategies.
Serve as the senior strategic liaison to FDA promotional review divisions (OPDP and APLB), overseeing high-impact interactions, guiding complex regulatory negotiations, and ensuring consistency and quality in correspondence and advisory submissions.
Define and shape innovative, compliant regulatory strategies and solutions for highly complex and business-critical promotional concepts, enabling enterprise objectives while proactively mitigating regulatory risk across the portfolio.
Lead the oversight and evaluation and positioning of product claims for assets in development, ensuring scientifically robust, compliant messaging and guiding the development of Important Safety Information (ISI) and Brief Summary documents.
Establish and advance the strategic framework for advertising and promotion processes, standards, and SOPs, driving continuous improvement, governance, and operational excellence across the organization.
Lead enterprise interpretation of evolving regulatory trends, guidance, and enforcement activities, and proactively shape organizational strategy by advising senior Regulatory Affairs leadership, review committees, and cross-functional stakeholders on implications for business decisions and compliance.
Identify and provide solutions during labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.
Oversee and provide direction on regulatory communications, including responses to FDA action letters and high-visibility interactions with OPDP and APLB.
Champion and oversee department-wide capability building, including the strategy, design, and execution of training programs to strengthen organizational expertise and compliance awareness in promotional regulations.
Serve as a key strategic leader across the organization, influencing senior stakeholders across Marketing, Legal, Medical, and Regulatory functions to enable compliant, effective, and business-aligned promotional execution.
Provide leadership oversight for internal audits and CAPAs in partnership with Quality, ensuring strong governance, regulatory alignment, and continuous improvement in compliance practices.
Is seen as a leader and is sought out by peers. Creates capacity to provide support to team members. Proactively seeks opportunities to take on more complex projects and provide promotional regulatory training and coaching to team members. Mentors new hires.
Influence and drive alignment with senior commercial and functional leadership, building consensus and shaping decisions to balance business objectives with regulatory requirements.