VP, International Regulatory Sciences and IDM Head
VP, International Regulatory Sciences and IDM Head
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$ 315000 - 525000
1 Vacancy
Job Description
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.
This position will lead the International Regulatory Sciences organization and manage capabilities for the international markets serving as the go to leader for regulatory matters in all markets outside of the US. The leader will have a global strategic mindset and expertise of drug development processes deep understanding of the regulatory environment globally as well as commercial priorities for products across the entire Pfizer Portfolio.
The goal of the position is to provide strategic guidance as well as manage international regulatory resources in alignment with regulatory requirements and enterprise priorities. In addition to oversight of Emerging Markets and China regulatory strategy the leader will have direct accountability for driving regulatory strategies and activities for the IDM markets serving as the direct manager of the IDM cluster leads. This position will serve as manager to country-based regulatory strategy colleagues in the IDM region.
This leader will:
- Ensure international regulatory input is effectively articulated and reflected in relevant global regulatory strategy to support clear and decisive development and commercial decision-making
- Gain timely approvals with optimal labels for Pfizer products through use innovative pathways and effective regulatory support for product registration in all international markets
- Effectively balance priorities within markets and across regions by dynamically allocating and directing resources to assure qualified regulatory representation and support for products and projects
- Ensure compliance of marketed products throughout the product lifecycle and support regulatory product defense activities as needed
- Take an active role in regional regulatory policy priorities by representing Pfizer in appropriate scientific or regulatory activities (e.g. membership in advisory councils and/or trade associatesl association) to influence the regulatory environment as appropriate
- Partner across GRS to align and deliver priority programs and projects.
- Serve as key stakeholder and partner for International Commercial Organization regularly communicating the regulatory implications of emerging data and implications of external regulatory environment changes
This position will balance priorities within markets and across regions dynamically allocating and directing resources to assure qualified regulatory representation and support for products and projects. The leader is accountable for ensuring that regional considerations are reflected in the relevant global regulatory strategy. This is accomplished through close partnership with therapeutic area aligned Global Regulatory Strategy teams.
The leader 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 leader 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 leader will maintain a strong collaborative relationship with GRS leaders and leaders in Commerical and PGS and represent International Regulatory and the GRS organization on senior leadership committees and meetings within or across Pfizer.
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/labelling and artwork changes)
- Ensures compliance standards met in each country and any remediation plans identified and actioned
- Leads 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.
- Model strong leadership and project management techniques including the establishing and chairing an IDM/EM Regional Strategy Forum (comprising Category Regional lead roles and in-country leads and other key stakeholders) to ensure aligned global positions priorities and inputs to deliverables. Participate and contribute to content
- Provide strategic input to the regional and local commercial leadership teams anticipate what Regulatory needs to contribute to achieve business objectives e.g. BU Strategic and Operating plans and deliver plans to achieve these objectives.
- 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.
- Engages in appropriate activities in order to influence the regulatory environment including developing and enhancing relationships with key external entities at the regional level
- May assume responsibility for other activities/functions within GRS as required.
- Developing all International Regulatory Sciences colleagues at the region and site to help them achieve their full potential.
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
ORGANIZATIONAL RELATIONSHIPS
- Reports to Head GRS
- Member GRS Leadership Team
- Works with all relevant international stakeholders including Finance PX International Commercial Organization Legal and PGS
- Works with external contacts including Regulatory Authorities (FDA EU MHLW etc) professional scientific and regulatory groups trade associations and consultants
- Manages up to 550 employees (plus contractors) in 70 countries
Other Job Details:
Last Date to Apply: July 02 2025.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.
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.
Required Experience:
Exec
Employment Type
Full-Time
