The Vice President, GRA Digital Health, Medical Devices & Combination Products reports to the Vice President, GRA CMC and Hospital Category and has a dotted line to the Senior Vice President, Global Regulatory Affairs. This role serves as the principal regulatory representative for the Digital Health business, and is responsible for regulatory strategy including clinical development, submissions and interactions with regulatory agencies covering all Digital Health internal programs and business development opportunities The role also supports medical devices (including IVD companion devices) and combination product platforms for all product areas of Pfizer, both development and life cycle maintenance (40% of Pfizer's portfolio).
The role will serve as a senior regulatory leader providing expertise and operating across the highest level of the company to drive strategy, implementation, and successful delivery of product approvals. This is a highly visible position which requires strategic thinking, leadership, stakeholder management and exceptional communication skills.
Directs the development of global regulatory strategy to deliver product approvals for digital health, medical device, and combination products for all product areas (biosimilars, brands, sterile injectables and anti-infectives).
Influences new legislation and regulatory policy by participating in industry task forces and presenting at professional meetings. Analyzes and anticipates the regulatory environment to identify changes and develop strategies that may impact customers, products and/or operations.
Oversees the regulatory support for lifecycle management of digital therapeutics, medical devices and combination products globally. This includes working collaboratively with PGS, safety and medical to ensure medical device quality system and ISO compliance at global and site level. Also includes accountability and responsibilities for the EU Authorized Representative role for Global Regulatory Affairs.
Collaborates with World Research Development Medical (WRDM), Global Product Development (GPD) and Digital & AI Unit leadership to the lead the regulatory strategy for digital medicine, providing end to end support from concept to approval and lifecycle management
Represents the company in interactions with global regulatory authorities and external business venues such as technical meetings, regulatory forums, and with industry groups to leverage company positions and influence legislation and guidelines impacting the regulatory environment.
Ensures that regulatory development and lifecycle resources are focused on harmonized goals in line with the Digital, Program Management, Research & Development, Marketing and Corporate Development and Commercial for all digital health, medical devices, and combination products.
Delivers milestones in a timely, cost-effective, and high-quality fashion within budget and resource forecast.JOB RESPONSIBILITIES
Indicate the primary responsibilities critical to the job.
- Serves as the senior global regulatory representative at the governance, strategic, technical, and portfolio level responsible for regulatory decisions
- Ensures global regulatory strategies for all projects and products are developed and implemented, in alignment with the overarching strategy and vision for Digital Health, as well as all medical devices and combination products in the Pfizer portfolio
- Provides regulatory expertise to inform business strategy; informsthe relevant leaders regarding options and recommendations, specific program strategies, execution, progress, and critical issues
- Responsible for developing and maintaining an in-depth regulatory knowledge of the growing portfolio including current and emerging global guidelines and regulators, relevant regulatory approaches, and actions; and status of competitor products
- Engage in appropriate activities to influence the global regulatory environment for Digital Heath, medical devices and combination products.
- Directs innovative approaches to regulatory submissions by developing strong and positive working relationships with regulators, professional bodies, external experts, and opinion leaders.
- Solid understanding of and experience with global processes and interactions essential for regulatory activities pre and post market.
- Leads and coordinates a cross-functional team of Global Regulatory Affairs colleagues across all lines ensuring the team has appropriate resources and technical expertise to meet strategic objectives
- Ensure regulatory deliverables in place and deliver milestones in a timely, cost-effective, and high-quality fashion and within budget and resource forecast (line plan/GRS/PRS/regulatory risks)
- Partnering with PGS and other functions, support a sustainable quality system across Pfizer for medical devices and combination products. Ensure compliance standards met globally and any remediation plans identified and actioned for medical devices and combination products. Ensure close working relationship with PGS to support this work.
- Monitors, identifies, and communicates program strategic, technical, or operational risks; ensures development and implementation of risk mitigation plans
- Collaborates with the Category CDO (GPD), CSO of AI, Digital Sciences (WRDM) and Digital Health Business Unit (Chief Digital Office) to inform clinical development program design, registration objectives, and support seamless transition plans from early to late-stage clinical development that fosters efficient end-to-end development
- Provides key regulatory input into relevant business development opportunities
- Develops close partnership and cross-functional collaboration and communication with a broad group of senior internal stakeholders within Digital, GPD, WRDM, and PGS.
- Responsible for creating and overseeing regulatory organization for medical devices, & combination products
- Drives technical excellence and functional competency of colleagues through effective oversight, coaching, mentoring, and training
- Champions flexible approaches to ensure efficient and effective resource utilization.
- Ensures learning embedded in the organization.
- Promotes a culture of innovation and creativity
- Maintains personal compliance with training requirements, and fulfills any additional responsibilities as written in SOPs and guidance document
- Education and Experience
- Advanced Scientific Degree (M.D., Ph.D., Pharm.D., M.Sc.) or equivalent experience in device, combination development and commercialization.
- 12-15+ years demonstrable experience in device or combination product development in Regulatory Affairs / Health Authority. Proven track record of success in negotiating with Health Authorities and in representing interests to internal and external stakeholders.
- 5+ years experience working with emerging technologies; demonstrated ability to rapidly adopt and utilize new digital technology
- Demonstrated leadership experiences with increasing scope of responsibility
- Proven ability to work collaboratively within regulatory organization and across wider Pfizer including senior management and stakeholders Established collaborative relationships within the Research, Development, PGS, and Commercial environments.
- Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
- Proven ability to function autonomously at a senior level in a highly matrixed organization.
- Technical Skills Requirements
- Global Regulatory Experience - demonstrated experience with medical devices (including SaMD) and combination products including pharmaceuticals/biologics during development, submission, approval and post market. Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines. Experience and credibility working with global regulators on pre and post market regulatory programs/issues.
- Therapeutic Area Knowledge - Demonstrated understanding of the complexities and recent developments in Digital Health and Device Development strategies; confident discussing commercial and regulatory issues
- Presentation and Analytical Skills - Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data to a variety of scientific and non-scientific audiences
- Risk Agility - Able to manage risk and uncertainty with track record of good decision-making based on sound mix of analysis and judgment
- Conflict Management - Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and settle disputes equitably; provides direct and actionable feedback; prepared to take responsibility for a decision made and support this, even though it may be unpopular
- Networking and Alliance Building - Achieves results through influence in a matrix organization and leverages contributions of colleagues with diverse expertise; builds strong alliances across internal/external stakeholder groups; proactively manages governance
- Agile and entrepreneurial - Able to drive, anticipate, influence, and manage change, demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change to deliver maximum value for all stakeholders
- Last day to apply: September 11, 2022
- This is a GJL 110
Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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