Mission

Pharmaceuticals

DirectorPromotionalRegulatoryAffairs

$200–300k ~AI est. United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Director Promotional Regulatory Affairs at Mission. Skills: Promotional regulatory affairs, FDA regulations, Risk management, Cross-functional collaboration. Drive regulatory review for promotional materials. Conduct risk assessment for promotional materials”

What You'll Achieve.

Accelerate responsible growth; Earn patient and prescriber trust; Enable confident brand execution; Ensure promotional materials meet highest standards; Protect brand integrity; Increase clarity in review; Increase speed in review; Increase quality in review; Inform proactive planning; Achieve measurable outcomes; Elevate team capability; Reinforce credibility; Advance patient impact; Raise bar for promotional excellence

Industry & Context.

Pharmaceuticals
Problems you'll solve

Anticipate risk; Convert risk into strategy; Troubleshoot competitor complaints

What They're Looking For.

Must Have

Bachelor’s degree in science, 3+ years’ experience in promotional regulatory affairs, 5+ years total experience in pharmaceutical/biotech industry, Knowledge of FDA promotional regulations, Ability to apply knowledge in review, Knowledge of drug development processes, Knowledge of labeling processes

Nice to Have

Advanced degree in life sciences, pharmacy, law, or related discipline, 10+ years of experience in US promotional regulatory affairs, Direct OPDP/APLB interactions, Resolution of advisory or enforcement matters, Experience leading MLR processes, Experience operating within digital review systems, Launch-to-lifecycle leadership, Proven ability to design effective regulatory training, Demonstrated influence at senior levels, People leadership experience, Track record of coaching high-performing teams

What You'll Do.

Drive regulatory review for promotional materials

Conduct risk assessment for promotional materials

Lead regulatory strategy development

Implement regulatory strategy

Advise business leadership on Brand strategy

Ensure claims align with regulatory expectations

Provide input to global teams

Translate insights into guidance

Serve as liaison with OPDP/APLB

Manage requests for FDA advisory review

Address enforcement actions

Adjudicate competitor product complaints

Evaluate brand regulatory training needs

Develop and deliver training

Build regulatory acumen

Follow established processes

Enhance established processes

Develop PRA guidance documents

Monitor regulatory agency activities

Monitor guidance documents

Distill and share implications

Contribute to team objectives

Represent company as subject matter expert

How You'll Work.

Team & Collaboration

Partner with Medical, Legal, Commercial, Corporate Affairs; Collaborate with MLR planners; Collaborate with reviewers; Collaborate with asset owners; Partner with internal/external Learning teams; Partner with PRA Skill Center; Collaborate with cross-functional partners; Work with enterprise leaders

Communication Scope

Clear communication; Claims development; Guidance documents; Thought leadership

Process & Methodology

Launch planning, Lifecycle management

Full Job Description

Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust? This role translates science into clear, compliant communication across healthcare professionals, consumers, and payers—so that what we say is as strong as the medicines we deliver. As Director of Promotional Regulatory Affairs, you will set the regulatory guardrails that enable confident brand execution and speed. You will partner closely with Medical, Legal, Commercial, and Corporate Affairs to shape claims early, guide labeling implications, and ensure promotional materials meet the highest standards across all channels—from print and broadcast to digital and omnichannel. Your expertise with FDA engagement will help anticipate risk and convert it into sound strategy. Do you thrive where fast decisions matter and your judgment sets the pace for launch and lifecycle excellence? Join a high-energy, commercially savvy environment that develops leaders who know how the enterprise runs and what excellence looks like in bringing innovation to patients. **Accountabilities:** \- Regulatory Promotion Review: Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments and all media types, including sales and faculty training, scientific exchange, and Corporate Affairs communications, through established systems. \- Risk and Strategy Leadership: Lead innovative regulatory strategy development and implementation, including risk identification and contingency planning that safeguard brands while enabling bold, compliant storytelling. \- Cross-Functional Partnership: Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation; advise business leadership on Brand strategy to ensure claims and evidence align with regulatory expectations. \- Global Input for US Impact: Provide input to global teams on how proposed TPP

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