Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Executes global CMC regulatory strategies for post-approval pharmaceutical changes, including product change assessments, health authority responses, regulatory submissions, dossier updates, and technical justifications. Coordinates cross-functional reviews, document sign-off, query and commitment management, risk escalation, and regulatory system maintenance. The role requires applying international regulatory guidelines and managing multiple projects under team-lead guidance.
Top Skills:
DatabasesDocument Management SystemsGdmsWindowsNavigationPdmPublishing ToolsSpaSubmission Management ToolsTrackwise
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports global pharmaceutical regulatory CMC activities for license renewals and annual reports. Authors and compiles CMC dossier contributions, reviews post-approval changes and stability information, applies regulatory guidelines, develops technical justifications, coordinates document reviews, manages commitments and queries, and updates submission components. Collaborates with global regulatory strategists, manufacturing, supply, and cross-functional teams while monitoring timelines, risks, compliance, and submission accuracy.
Top Skills:
GdmsPdmPearlSpa
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports CMC regulatory activities for pharmaceutical license renewals and annual reports across global markets. Responsibilities include authoring and compiling regulatory dossier contributions, reviewing technical and stability information, applying U.S. regulatory guidelines, coordinating document reviews and approvals, updating dossier components, managing timelines and risks, and using Pfizer regulatory systems. Requires postgraduate education in Pharmacy or Science and foundational knowledge of post-approval regulatory requirements.
Top Skills:
GdmsPdmPearlSpa
Lead moderately complex digital projects, guide teams, drive process improvements, analyze product analytics and support trends, ensure regulatory-compliant deliverables, and contribute to digital strategy and roadmaps.
Use Your Power for Purpose
At Pfizer, technology impacts everything we do. Our digital and 'data first' strategy focuses on implementing impactful and innovative technology solutions across all functions, from research to manufacturing. By digitizing drug discovery and development, identifying solutions, or making our work easier and faster, you will be making a difference to countless lives. Your dedication and hard work will be instrumental in helping Pfizer achieve new milestones and make a positive impact on patients worldwide.
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Information & Business Tech
At Pfizer, technology impacts everything we do. Our digital and 'data first' strategy focuses on implementing impactful and innovative technology solutions across all functions, from research to manufacturing. By digitizing drug discovery and development, identifying solutions, or making our work easier and faster, you will be making a difference to countless lives. Your dedication and hard work will be instrumental in helping Pfizer achieve new milestones and make a positive impact on patients worldwide.
What You Will Achieve
In this role, you will:
- Lead and guide moderately complex projects, effectively managing time and resources
- Apply skills and discipline knowledge to contribute to departmental work
- Make decisions to resolve moderately complex problems and develop new options in non-standard situations
- Work independently on assignments, seeking guidance on unusual or complex problems
- Utilize judgment and experience to become a resource for others and guide operational teams
- Facilitate agreements and collaboration between teams to ensure successful project delivery
- Act as a thought leader on emerging digital technologies, contributing to the vision, strategy, design, and roadmap of digital products
- Analyze support trends, lead process improvements, and evaluate data to understand user behavior and business trends
- Ensure project management deliverables comply with regulatory standards and maintain strong partnerships with Pfizer teams through effective engagement models
Here Is What You Need (Minimum Requirements)
- BA/BS or MBA/MS with 5-10 yrs of relevant experience or PhD/JD with any years of experience
- Demonstrated experience of various Information Technology practices
- Experience with System Application and Products eDoc framework
- Familiarity with product analytics and strong ability to carry out analysis related to customer journey, user activity, product/feature performance, and other digital analytics
- Understanding of financial concepts and key success factors for business performance
- Knowledge of management reporting requirements and functional design
- Excellent communication skills
Bonus Points If You Have (Preferred Requirements)
- Master's degree
- Relevant pharmaceutical industry experience
- Management consulting experience
- Experience with Agile Software Delivery and/or Scrum Master Certification
- Ability to mentor and guide other colleagues
- Strong collaboration and team facilitation skills
- Ability to analyze support trends and lead process improvements
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Information & Business Tech
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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