JOB SUMMARY
Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global development that changes patient lives throughout the product life cycle.
The Head of Global Labeling and U.S. Advertising & Promotion has overall accountability for ensuring the high quality, timely development & maintenance of all labeling & commercial artworks for both Global (above-country labeling documents) and International (nationally approved labeling) documents, as well as US-based promotional materials.
This function covers all aspects of the domain deliverables in scope, e.g. strategy, operations, execution, compliance and oversight including product Investigator’s Brochure, Company CDS, USPI, EU SmPC, local market prescribing information, all related patient-labeling documents, artwork & packaging materials, and all US-specific materials for drugs and vaccines in line with global and local regulatory requirements. This role has overall accountability for ensuring proper oversight and compliance monitoring of activities within labeling, artwork and Ad Promo domain.
This role is accountable for providing strategic guidance & recommendations to therapeutic program teams and ensuring the development of innovative and competitive labeling and promotional materials for all Pfizer assets. This role plays a vital part in ensuring adherence to Pfizer labeling & US promotional policies including utilization of the Investigator’s Brochure and Company Pfizer Reference Label (PRL) and in driving procedures and governance decisions that ensure consistency of application and uniformity in approach taken by product teams.
This role collaborates closely with enterprise stakeholders to ensure the creation of an up-to-date and effective target product label that guides the innovative development of Pfizer products. Specifically, this role is accountable for driving and overseeing the development, maintenance & endorsement of North Star from origin to completion. The role represents GRS in appropriate governance and risk management committees.
This role will represent GRS & Pfizer on global or divisional activities and routinely engage/influence the external environment on related areas of expertise. This position provides executive leadership and direction setting for the overall function, overseeing ~200+ colleagues, developing strategies for execution & identifying emerging business needs to ensure readiness, compliance, and appropriate resolution of challenges and/or evolving requirements.
JOB RESPONSIBILITIES
- Ensures the high-quality creation, maintenance, and execution of all labeling & artwork documents throughout product lifecycle.
- Provides strategic advertising and promotional guidance to program and asset teams to enable efficient competitive development of drugs and vaccines based on regulatory precedent, emerging data and competitive landscape.
- Ensures proper analysis of competitive landscapes and influences product teams to ensure availability of up-to-date therapeutic information.
- Ensure staff can serve as strategic partners to TA Leads, BU heads, and Research & Development and Commercial Sr. leaders by providing effective strategic guidance to programs and asset teams such that competitive development of drugs & vaccines occurs
- Identify and optimize underlying processes and principles for developing strategic labeling claims, sets direction for Pfizer labeling & artwork organization, and establishes global/corporate policies.
- Champion and implement the adoption of digital tools including artificial intelligence enhance decision-making, optimize workflows, drive innovation and efficiency
- Ensures adherence to relevant policies & procedures and external regulatory requirements.
- Plans and implements ways to enable staff to remain knowledgeable and up to date on labeling requirements, pending regulations, competitive intelligence, and industry trends.
- Ensures proper oversight is provided for vendors and contractors. Strategically utilizes resources outside direct authority and is responsible for relevant financial obligations.
- Engages with stakeholders across the organization to ensure that actions taken follow applicable regulations and Pfizer controlled documents and result in high quality, timely outputs that maintain labeling and AdPromo compliance.
- Ensure that proper analytics & insights are conducted on quality and performance metrics in order to establish proper corrective action plans and risk mitigations. Maintains an organization structure such that metrics continually evolve in line with portfolio and business function expectations.
- Maintains organization to oversee and ensure compliance with internal policies and procedures and to ensure compliance with external Regulatory authorities’ expectations. This includes ensuring adequate support for internal and external audits and inspections; prioritizing accordingly to ensure business needs are met.
- Effectively addresses team conflicts that have implications across the BU/portfolio. Resolves or escalates to designated governance/executive committees as deemed appropriate.
- Responsible for staff talent retention, development, succession planning, career development and performance management to ensure that resources are appropriately developed and deployed.
- Provides clear vision, mission and strategic guidance to the organization.
- Champions innovative approaches and thoughtful risk-taking within domain area.
- Partners with Clinical, Regulatory, Safety, Legal, Commercial and other global leaders as appropriate to ensure alignment of priorities, strategies and key objectives.
- Collaborates with peers at other pharmaceuticals and global regulatory authorities as appropriate to maintain a leadership role in direction and development of regulations and guidance.
- Influences external environment in relation to areas of responsibility through participation in industry organization associations and working groups.
QUALIFICATIONS
- B.S./B.Sc. in Pharmacy or Life Sciences required. M.S./Ph.D. or other advanced academic qualification/degree preferred.
- 20+ years direct experience in managing global/multi-national regulatory function in the pharmaceutical environment, preferably in the domain area of labeling and/or advertising & promotions.
- Proven success with managing diverse global teams and effectively developing high performing teams and coaching colleagues to achieve their highest potential.
- Proven accountability and demonstrated excellence in interpersonal communication, negotiation, influencing, and problem-solving capabilities.
- Recognized for ability make objective decisions, which significantly impact business, staff, department, or Pfizer portfolio.
- Experience in monitoring and influencing external environment.
- Demonstrated ability to successfully implement large-scale business process improvements and transformations.
- Demonstrated ability to exhibit sound judgment, objectivity and deal with ambiguity and change.
- Mastery of processes, tools and techniques for executing highly complex programs within est. timeframes.
- Demonstrated strategic & analytical mindset – developing effective business and competitive strategies for current and future industry trends and internal organizational challenges.
- Demonstrates AI fluency by effectively leveraging artificial intelligence tools and concepts to enhance decision-making, optimize workflows, and drive innovation, while understanding ethical, regulatory, and business implications of AI adoption.
- Maintaining global perspective and keen awareness of global, regional and local filing practices & expectations.
- Exemplifies leadership behaviors consistent with the company’s behaviors and values. Motivates peers and colleagues through example, commitment, loyalty, and enthusiasm.
- Demonstrated success at deeply understanding customer needs and developing strategies that meet business needs; including regulatory agencies, internal clinical, medical, safety & commercial staff.
- Ability to effectively network and build lasting business partnerships. Building network of alliances with key customers, utilizing their expertise to drive strategic thinking.
- Excellent influence; using a wide range of effective communication styles and creating an inclusive and trusting environment with both internal & external stakeholders. Ability to use diplomacy and tact and diffuse high-tension situations comfortably.
- Demonstrated leadership in providing direct, constructive, and actionable feedback to direct reports and staff within line. Provides adequate training and upskilling opportunities where appropriate.
- Understands importance of managing change and works to ensure effective implementation of new procedures and systems.
- Comfortable making decisions, coping with ambiguity and bringing the team along in such situations.
- Demonstrates AI fluency by effectively leveraging artificial intelligence tools and concepts to enhance decision-making, optimize workflows, and drive innovation, while understanding ethical, regulatory, and business implications of AI adoption.
ORGANIZATIONAL RELATIONSHIPS
- Reports to Senior Vice President, Global Regulatory Sciences
- Internal interface with all functions within GRS
- Internal interface with functions outside GRS, such as Commercial, Safety, Clinical, Quality, Medical, Reg Law, Pfizer Country Offices, and various enabling/support functions
- Manage Executive steering committees and governances as appropriate
- External interface with regulators, industry associations, vendors, and various Pfizer partners
RESOURCES MANAGED
- Manages ~5-10 direct reports and functional department comprised of ~200 colleagues, various contractors and vendors. Effectively manages global, respective budgets associated with organizations, ensuring financial targets are adequately established and achieved.
Other Job Details:
- Last Date to Apply for Job: November 20, 2025
- This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed.
The annual base salary for this position ranges from $280,400.00 to $467,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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Regulatory Affairs