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Use Your Power for Purpose
We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines.
What You Will Achieve
JOB SUMMARY:
- Single point of contact (SPOC) representing regulatory at regional level for the identified region and Therapeutic Area (TA) products to facilitate the best-in-class support for new product registration and lifecycle management activities.
- Collaborate and engage with multiple partner lines across Pfizer including Integral Regulatory Strategists (GRL, EM RS, CMC PS), Country Regulatory Strategists (CRS), Regulatory Operations, Clinical, Commercial,
Medical and Supply Chain to align on priorities and strategies to effectively deliver regulatory submissions in line with business and supply plans.
- Execute high quality communications with both external BoH and internal stakeholders to articulate understanding of regulatory strategies, timelines and associated complexities.
- Provide timely and decisive regulatory advice to enable stakeholders to make well-informed decisions on product development, lifecycle planning, business development and supply planning.
- Ensure adherence to regulatory processes and systems per assigned responsibility identified in internal SOPs and policies.
JOB RESPONSIBILITIES:
Regulatory Strategy and Expertise:
- Lead the development and implementation of regional regulatory strategies for assigned product(s) that are in-line with business objectives, ensuring regulatory strategies are adequately reflected in relevant country plans (e.g. business development or manufacturing supply) and alignment is achieved between regulatory activities and rele
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