Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead project management for clinical database design, build, and maintenance. Ensure data integrity, compliance with SOPs and Pfizer standards, perform impact analyses, manage risks, and collaborate with cross-functional teams to deliver high-quality clinical data capture solutions.
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Owns availability, performance, and continuity for a portfolio of R&D applications. Manages vendors, SLAs/OLAs, incidents, change and lifecycle planning, DR testing, monitoring and performance analysis. Partners with shared services, client partners, projects and business to ensure production readiness, automation opportunities (including GenAI), and compliance in a regulated environment.
Top Skills:
GenaiItilSfia
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead administration and continuous improvement of Veeva eQMS for Regulatory Quality Assurance. Own access management, release coordination, reporting, and user documentation. Provide Vault configuration expertise, triage enhancement requests, represent Digital Systems in cross-functional programs, support data extracts and reporting, and drive AI-enabled process improvements and platform transformation within a GxP-regulated pharmaceutical environment.
Top Skills:
Ai-Enabled ToolsDataikuDssEqmsMicrosoft Power AutomatePower BISnowflakeSpotfireSQLVeevaVeeva Vault Eqms
Functions as a CMC strategist for the development of CMC regulatory strategies, submissions and compliance activities for commercial pharmaceutical products supporting HBU's Business. Work is periodically reviewed by Team Lead.
Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post approval activities. Prepares the CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans.
Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
Primary accountable for assigned CMC products, managing daily delivery of regulatory and strategic activities, including post-approval changes and compliance activities.
May represent CMC during interactions with internal partners either directly or in conjunction with Team Lead.
Resolve issues and manage regulatory risks within project teams.
Makes decisions to resolve moderate problems in standard situations as per the guidance and policies and escalates complex issues / risks to appropriate leadership.
Ensure compliance to Pfizer's training activities (e.g. functional, compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums & learning opportunities, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.
Utilize Pfizer's CMC systems, i.e. GDMS, PDM, SPA, Rosetta, PEARL, etc., as appropriate.
Work Location Assignment: Hybrid
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 .
Regulatory Affairs
Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post approval activities. Prepares the CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans.
Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
Primary accountable for assigned CMC products, managing daily delivery of regulatory and strategic activities, including post-approval changes and compliance activities.
May represent CMC during interactions with internal partners either directly or in conjunction with Team Lead.
Resolve issues and manage regulatory risks within project teams.
Makes decisions to resolve moderate problems in standard situations as per the guidance and policies and escalates complex issues / risks to appropriate leadership.
Ensure compliance to Pfizer's training activities (e.g. functional, compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums & learning opportunities, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.
Utilize Pfizer's CMC systems, i.e. GDMS, PDM, SPA, Rosetta, PEARL, etc., as appropriate.
Work Location Assignment: Hybrid
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 .
Regulatory Affairs
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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