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Use Your Power for Purpose
In an ever-changing regulatory environment, Pfizer relies on a knowledgeable and skilled Regulatory Affairs team. As part of this dynamic team, you will review and interpret increasing regulatory requirements and their associated commercial pressures to ensure the best patient care. Our patients depend on dedicated colleagues like you, experts in your field, who prioritize their well-being above all else. Your work will have a direct impact on ensuring that our products meet the highest standards of safety and efficacy, ultimately contributing to the health and well-being of patients worldwide.
What You Will Achieve
In this role, you will:
● Provide strategic regulatory input to support local business objectives under the guidance of the Country Regulatory Head.
● Train the Pfizer Consumer Healthcare Worldwide Strategy and Regulatory team on Pfizer systems for regional integration.
● Coordinate translations and manage regulatory aspects of projects, including preparing and submitting documents to regulatory agencies.
● Support regulatory compliance by monitoring and reporting compliance as required by Worldwide Strategy and Regulatory systems.
● Ensure licenses comply with local regulations by maintaining corporate regulatory processes, SOPs, and systems.
● Collaborate with HUB colleagues to align support with local High Availability requirements and seek continuous improvement in HUB processes.
● Manage core package builds, contribute to Clinical Trial Application documentation, and author necessary documents.
● Regularly update and verify data according to standard operating procedures and guidelines.
● Provide guidance or lead moderately complex projects, managing time and resources effectively.
● Apply skills and knowledge to contribute to departmental work, make decisions to resolve moderately complex problems, and operate independently in ambiguous situations.
Here Is What You Need (Minimum Requirements)
● BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
● Strong written and verbal communication skills
● Solid understanding of commercial activities and Current Good Manufacturing Practices (part of GxP)
● Ability to work effectively across functions and develop productive, collaborative relationships
● Experience in the Over the Counter or pharmaceutical industry, particularly within the global regulatory environment
● Regional and country-specific regulatory experience, such as submission processes and product life cycle management activities
● Proficiency in managing projects and preparing resource forecasts
Bonus Points If You Have (Preferred Requirements):
● Master's degree
● Relevant pharmaceutical experience
● Experience of conducting, managing, or participating in the audit process
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
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