Senior Program Director, Commercial Regulatory Affairs

Position Summary

The Senior Program Director is a senior-level individual contributor responsible for providing strategic and operational leadership for commercial regulatory review activities within the U.S. market. This role leads cross-functional review committees responsible for evaluating and approving advertising, promotional, and communications materials for pharmaceutical products, ensuring compliance with FDA regulations, healthcare compliance requirements, and company policies.

Key Responsibilities

• Regulatory and Committee Leadership
  Lead and chair cross-functional Program Review Committees (PRCs) for assigned therapeutic areas, products, or business initiatives.
  Serve as the primary regulatory decision-maker for assigned review committees, ensuring promotional and marketing materials comply with applicable regulations and internal policies.
  Provide strategic regulatory guidance to commercial teams during development and execution of marketing and promotional campaigns.

• Interpret and Apply Regulations
  Interpret and apply FDA regulations, industry guidance, and company policies to support compliant business decisions.
  Lead regulatory strategy for product launches, lifecycle initiatives, and complex promotional programs.

• FDA and Regulatory Affairs Activities
  Support product labeling activities, core data sheet updates, and broader regulatory strategy development.
  Represent the organization in interactions with the FDA and support official regulatory communications.
  Review and approve required promotional submission documents, including FDA Form 2253 submissions.
  Monitor evolving regulatory requirements, enforcement actions, guidance documents, and industry trends, communicating relevant updates to stakeholders.

• Develop Strategies
  Develop and implement strategies for advertising, marketing, and communication-related regulatory submissions.

• Strategic Leadership and Cross-Functional Collaboration
  Partner with commercial leadership to influence marketing strategies and promotional objectives.
  Lead cross-functional projects and committees with significant organizational impact.
  Provide regulatory expertise and recommendations to support product, portfolio, and business objectives.
  Serve as a regulatory subject matter expert and trusted advisor across multiple functional areas.
  Support process improvements, organizational initiatives, and departmental planning efforts.

• Team Support and Mentorship
  Provide day-to-day guidance, coaching, and mentorship to junior regulatory professionals.
  Share best practices and regulatory expertise to strengthen organizational capabilities.
  Lead special projects and strategic initiatives as assigned.

Qualifications

• Education
  Bachelor's degree required; preferred fields include Life Sciences, Law, Public Policy, Marketing, Business, Education, or a related discipline.
  Advanced degree strongly preferred (e.g., JD, MBA, MS, PharmD, PhD, or equivalent).

• Experience
  7+ years of experience in regulatory affairs, legal, compliance, policy, auditing, training, communications, or a related function within the biopharmaceutical industry.
  Regulatory advertising and promotion experience strongly preferred.
  4+ years of experience leading large-scale, cross-functional projects, programs, or initiatives with significant organizational impact preferred.

• Key Competencies
  Strategic Thinking
  Ability to develop long-term strategies and align regulatory objectives with broader business goals.
  Decision-Making
  Makes sound decisions in complex or ambiguous situations while effectively balancing regulatory, legal, and commercial considerations.
  Influence and Leadership
  Builds strong relationships, drives collaboration, and influences stakeholders across all levels of the organization without direct authority.
  Regulatory and Business Expertise
  Demonstrates deep regulatory knowledge and strong understanding of the pharmaceutical business environment.
  Change Management
  Effectively leads and supports organizational and process changes.
  Innovation and Problem Solving
  Identifies opportunities for improvement and develops creative solutions to complex regulatory challenges.
  Communication Skills
  Exceptional verbal and written communication skills, including the ability to translate complex regulatory concepts into clear, actionable guidance.
  Project Management
  Strong organizational skills with the ability to manage multiple priorities, timelines, and stakeholders simultaneously.

Benefits

• Health coverage
• Life insurance
• Disability insurance
• 401k benefits