Director, Global Regulatory Strategy
2 weeks ago
Work Location Assignment: Onsite/Hybrid
Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
What You Will Achieve
You will represent Pfizer as an Approval Liaison in the regulatory affairs team. You will play the critical role of providing strategic regulatory expertise as Global regulatory representative to Product Team(s).
As a Director, 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.
- Timely submissions and approvals with commercially attractive labelling across the regions.
- Ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).
Role may be combined with other Regulatory Role (i.e. regional US or EU regulatory role and/or Regulatory Lead for other projects).
Project(s) assigned could be in development and/or at post-authorization stage.
How You Will Achieve It- 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.
**Qualifications**:
Must-Have- Bachelor's Degree (BA/BS) and 10+ years of experience. MS, PharmD, PhD or MD preferred. Equivalent workplace experience can be considered.- 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.- Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.- Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations- Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.- Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior managers.- Negotiation skills - Can ne
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