The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Provide strategic regulatory expertise as Global regulatory representative to Product Team(s).
Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from North America, Europe, Emerging Markets, Japan.
Through the GRST, develop, align, manage and implement the global regulatory strategy.
Be accountable for delivering the project goals and aligning the regulatory strategy with global and business regional needs.
Be accountable for timely submissions and approvals with commercially attractive labelling across the regions.
Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).
Role likely to be combined with other Regulatory Role (i.e. regional US or EU regulatory role and/or Regulatory Lead for other projects).
Project(s) assigned can be in development and/or at post-authorization stage.
Responsible for the production, updating and communication of global regulatory strategies for assigned projects/ products, mechanisms of action and/or indications.
Provides regulatory expertise and leadership for the project/product.
Member of appropriate Project(s)/Product(s) teams.
In partnership with the Project/Product Team Leader (eg MTL, GCMTL, RPL etc.), accountable for the delivery of the Project/product goals according to the endorsed Global Regulatory Strategy.
Ensures appropriate representation for Pfizer for the project/product with Health Authorities.
Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.
Ensures that all regulatory development process commitments are clearly communicated, monitored and met.
Acts as the point of contact for all internal Pfizer communication regarding the status of the project/product on issues related to regulatory process and registration strategy
Mentoring, developing regulatory professionals who are assisting in meeting the project/product objectives.
Develop strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders.
Ensures rapid reporting of key project/product regulatory milestones and/or issues to the GRPL and other stakeholders as required.
Participates in appropriate governance committees, as necessary.
“Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.”
BS is required. MS, PharmD, PhD or MD preferred. Equivalent workplace experience can be considered.
Minimum 10+ years regulatory experience in the pharmaceutical/healthcare industry
Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST.
Advanced knowledge of US FDA and/or EU regulations.
Working knowledge of other regulations and their associated challenges for global development programs.
Direct experience with at least US and/or EU submissions and approvals.
Direct experience in communicating with major regulatory agency(ies) (ie FDA, EMA, Japan), as well as participating in/leading such interactions such as End-of-Phase 2, pre-submission meeting(s).
Understanding of clinical trial design and management, including data flow process.
Experience working in a highly matrixed, global and multi-site environment.
Track record of having supported at least one project of high complexity and provided strategic direction.
Experience within different therapeutic areas and at different stages of products life cycle.
Eligible for Employee Referral Bonus: Yes
Additional locations: NYC, NY or Pearl River, NY or Collegeville, PA
Internal Number: 4777626
About Pfizer Inc.
Pfizer Inc: Working together for a healthier world
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.