This position will lead the regulatory sciences organization and manage capabilities for the International Markets (outside of the US). The incumbent will serve as the “go to” person for regulatory matters in all markets outside of the US. The incumbent will have a global strategic mindset and expertise of drug development processes, deep understanding of the regulatory environment globally, as well as commercial priorities globally for products across the entire Pfizer Portfolio. The goal of the position is to provide, maintain and direct regulatory resources in alignment with commercial priorities and regulatory requirements.

The incumbent will:  

• Represent Global Regulatory Sciences (GRS) International Regulatory Sciences on senior leadership committees and meetings within or across Pfizer
• Effectively manage the local regulatory country offices and regional hub colleagues
• Partner with GRS Leaders to align and deliver priority programs and projects.
• Serve as key stakeholder/partner/liaison for International Commercial Organization
• Optimize and consolidate International regulatory input to support clear and decisive development and commercial decision-making
• Gain timely approvals with optimal labels for Pfizer products and ensure effective regulatory support for product launches in international markets
• Ensure compliance of marketed products throughout the lifecycle
• Support regulatory product defense activities in markets

The remit is to represent the processes, policies and deliverables of GRS across Pfizer as well as the processes and policies to represent the priorities of the international markets within the GRS organization. The Head of GRS International Regulatory Sciences must work with other GRS leaders to achieve common goals.  The Head of GRS International Regulatory Sciences will manage, either directly or through matrix relationships, all the GRS International Regulatory Sciences staff, and will run a GRS International Regulatory Sciences leadership team. In this role they will ensure appropriate alignment of roles, responsibilities, and deliverables for projects/products and to the global GRS organization.

This position will balance priorities within markets and across regions, dynamically allocating and directing resources assure qualified regulatory representation and support for product or projects. The Head of GRS International Regulatory Sciences is accountable for ensuring that regional considerations for all projects and products are reflected in the relevant global regulatory strategy. This is accomplished through close partnership with therapeutic area aligned Global Regulatory Strategy teams.

The incumbent will be responsible for the effective communication and collaboration of the GRS functions across regions and ensure that all regulatory deliverables are of high quality and optimally coordinated. The position will be responsible for staff and talent management, career development and planning and performance management. The incumbent will conduct timely and efficient internal communication of resource and data quality matters, issues relating to the regulatory implications of emerging data, and implications of external regulatory environment changes to the appropriate stakeholders including senior leaders across Global Regulatory Sciences (GRS) and Commercial organizations.

The incumbent will maintain a strong collaborative relationship with GRS leaders and leaders in Commerical and PGS.

As a senior leader in GRS, the Head of GRS International Regulatory Sciences will collaborate with other stakeholders on regulatory policy issues by making a commitment to represent Pfizer in appropriate scientific or regulatory activities (e.g., membership in internal advisory councils and/or external association) to influence the regulatory environment.

JOB RESPONSIBILITIES

• Ensure projects delivered to time, cost and quality in each region to meet submission and approval targets for all submission types (including NME/Line extensions/variations/labeling and artwork changes)
• Ensures compliance standards met in each country and any remediation plans identified and actioned
• Convenes GRS International Regulatory Sciences leadership team assuring the establishment and maintenance of a collaborative performance-oriented culture that embodies the Pfizer values and advances the Pfizer Purpose Blueprint
• Owns resource allocation across International Regulatory function to projects and product teams
• Participates as a GRS senior leader in the development (e.g through governance bodies) in global strategies and translates those into region and possibly site-specific deliverables.
• Responsible for regional regulatory project/product governance, and global governance as appropriate.
• Management and development of large, global team with footprint spanning 70+ countries to help them achieve their full potential
• Engages in appropriate activities in order to influence the regulatory environment
• May assume responsibility for other activities/functions within GRS as required.

Qualifications/Skills

• MD, PhD, PharmD degree or equivalent advanced degree
• Minimum 15 years' experience in drug development/commercialization with a record of continuous learning and education regarding regulatory processes and policies
• Regulatory experience preferred with marketed drugs, Advisory Committee and other Health Agency Hearings including proven track record of strong credibility with regulators
• Proven track record of operational excellence, strategic partnerships
• Proven track record of successful management of staff and complex regulatory, program management or business issues
• Proven ability to lead with an innovative and agile mindset as well as creatively execute strategic plans
• Established relationships within the Research, Development and Commercial environments

The annual base salary for this position ranges from $285,000.00 to $475,000.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 45.0% 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.

Regulatory Affairs