Director, Regulatory Affairs – Promotion and Advertising Review

MSD

. Review and approve US promotional materials .

Posted 11/5/2026full-timeUnited StatesLead💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in FDA regulations and promotional review processes, with a strong emphasis on strategic regulatory solutions and compliance in the pharmaceutical industry. Proven ability to mentor and train team members while leading promotional regulatory strategies and initiatives.

Highest-signal resume keywords

FDA RegulationsPromotional Regulatory StrategyAdvertising ReviewRegulatory ComplianceStakeholder Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyPromotional Material ReviewLabeling DevelopmentClinical DevelopmentRegulatory PolicyFDA Approval ProcessesPharmaceutical Industry ExperienceScientific DisciplinesPromotional Regulatory TrainingAdvisory Comment Submissions

Soft Skills

DiplomacyInterpersonal SkillsNegotiation SkillsStrategic ThinkingAnalytical ThinkingCommunication Skills

Certifications & Qualifications

B.A. or B.S. Degree

Industry Keywords

PharmaceuticalBiologicsFDAPhRMA CodeDIAPromotional Review DivisionsOPDPAPLBTrade OrganizationsGlobal Target Product Information

About the role

Key responsibilities & impact

Review and approve US promotional materials
Serve as the promotional regulatory expert with legal, medical, and commercial colleagues
Liaise with and manage correspondence with FDA promotional review divisions OPDP/APLB
Handle complex regulatory questions and submissions for advisory comment
Propose compliant regulatory strategies and solutions for challenging promotional concepts
Partner with review, compliance, and commercial colleagues on integrated regulatory strategy from early development through approval and marketing
Lead assigned products’ promotional regulatory strategy, including rationale for Global Target Product Information (GTPI)
Provide solutions during labeling and global regulatory team meetings regarding promotional messages and claims
Maintain expert understanding of FDA advertising and promotion regulations, PhRMA Code and Principles, and company policies
Provide promotional regulatory training and coaching to team members
Mentor new hires
Lead departmental strategic initiatives for effective, compliant promotional regulatory review

Requirements

What you’ll need

B.A. or B.S. degree with an emphasis in science, health care or related fields
Minimum of ten years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines
Minimum of five years of direct experience as the primary reviewer of advertising and promotional materials
In-depth understanding of FDA regulations and company policies and procedures related to promotion development, implementation, and review processes
Strong diplomacy, interpersonal, and negotiation skills
Strong strategic and analytical thinking capabilities
Proven collaboration with external stakeholders, including FDA branches OPDP and APLB, alliance relationships, external consortia, and trade organizations such as DIA
In-depth understanding of clinical development, regulatory policy, labeling development, and FDA approval processes
Ability to identify solutions to complex promotional regulatory issues
Superior verbal and written communication skills
Valid driving license
No visa sponsorship available
US and Puerto Rico residents only

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, vision healthcare and other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Hybrid flexible work arrangement