
Director, Global Regulatory Sciences
At Pfizer, we are committed to bringing innovative and life-changing medicines to patients all around the world. As the Director of Global Regulatory Sciences, you will play a vital role in driving the success of our global regulatory strategy, ensuring compliance with regulatory requirements, and guiding the development and approval of our pharmaceutical products. We are seeking an experienced and driven leader with a deep understanding of the pharmaceutical industry and a strong background in regulatory affairs. If you are passionate about making a difference in the lives of patients and have the expertise to navigate complex global regulatory landscapes, we want to hear from you.
- Develop and implement global regulatory strategies to support the successful registration and approval of Pfizer's pharmaceutical products.
- Ensure compliance with all relevant regulatory requirements and guidelines across multiple regions and countries.
- Guide and advise cross-functional teams on regulatory matters, including clinical development, manufacturing, and commercialization.
- Monitor and analyze global regulatory trends and changes to proactively identify potential impact on Pfizer's products and strategies.
- Maintain relationships and communication with regulatory agencies to ensure a smooth and timely review and approval process.
- Lead and manage a team of regulatory professionals, providing guidance, mentorship, and development opportunities.
- Collaborate with internal stakeholders, such as research and development, legal, and commercial teams, to align on regulatory strategies and priorities.
- Drive the preparation and submission of regulatory applications, including INDs, NDAs, and BLAs.
- Oversee the maintenance of regulatory documents, ensuring accuracy, completeness, and compliance with regulatory standards.
- Represent Pfizer in external meetings and conferences related to regulatory affairs.
- Continuously evaluate and improve processes and procedures to optimize regulatory operations and ensure alignment with industry best practices.
- Proactively identify and mitigate potential regulatory risks and issues that could impact product development or approval.
- Act as a subject matter expert on global regulatory requirements and provide guidance and training to colleagues across the organization.
- Participate in cross-functional initiatives and projects to support business objectives and drive continuous improvement.
- Uphold Pfizer's commitment to ethical and responsible conduct by adhering to all applicable laws, regulations, and company policies.
Advanced Degree In Life Sciences, Pharmacy, Or Related Field, With A Minimum Of 10 Years Of Experience In Regulatory Affairs In The Pharmaceutical Industry.
Proven Track Record Of Successful Regulatory Submissions And Approvals From Major Global Regulatory Agencies, Such As Fda, Ema, And Pmda.
Strong Understanding Of Global Regulatory Guidelines And Requirements, With Experience In Developing And Implementing Global Regulatory Strategies.
Excellent Communication And Leadership Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And Manage Regulatory Staff.
In-Depth Knowledge Of The Drug Development Process, Including Clinical Trial Design, Data Analysis, And Risk Management, To Ensure Compliance With Regulatory Standards.
Risk Management
Project Management
Compliance Management
Clinical development
Cross-Functional Collaboration
Regulatory Strategy
Pharmaceutical Regulations
Labeling Expertise
Global Submissions
Health Authority Interactions
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Organization
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Director, Global Regulatory Sciences in San Francisco, CA, USA is between $160,000 - $200,000 per year. This range may vary depending on the specific company, industry, and level of experience of the individual. In general, those with more experience and in higher-level positions may command a higher salary within this range.
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Pfizer Inc. is an American multinational pharmaceutical corporation headquartered in New York City, with its research headquarters in Groton, Connecticut. It is one of the world's largest pharmaceutical companies.

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